Some PCB Designers Skip Risk Analysis. Should You?

In this video we are going to talk about something a little bit special. And uh it's going to be about risk analysis. It means uh when we are developing something, we need to be aware some of the things which are or may be very important because we don't want to develop the wrong direction, wrong product, and then, you know, find out like we have to redesign everything. Is this what we are going to talk about, Clements? Oh, yes, Robert. We are talking about the risk analysis and why it's important for you, not just because you have to have it. This is the most important tool that you can have in your arsenal as a developer to make sure you're developing in a safe, compliant way and at the end you don't have to do major, costly redesigns, but it's also the most effective tool to tell your CEO or whoever has to then sign it off on why things have to change or why you did things the way you did them. So, it's more of a tool than just a required document. But, don't get me wrong, it is a required document. You have to have this, but you can use it smartly. Okay, can we

have some simple example uh um how this risk analysis can help with a simple product. I would like to start with this so everyone can imagine like uh what we are going to talk about. Oh, yeah. So, if you are developing a product and you have to bring it to the EU market, it will most likely fall under the general product safety regulation. That safety regulation tells you in article five, you're only allowed to bring safe products to market. Period. That's it. Unsafe products, not allowed. So, we we've before talked about CE on our call, but this is already outside of CE. So, even if your product does not fall under any CE directives, it will very likely fall under this requirement. And it requires to have some assessment of if your product is safe. This is what the risk analysis is for. And the risk analysis um it defines your product in a basically in a written way. So, if you uh look at it topologically or how your product is made up of, you can identify it and know where it begins, where it ends, what are the inputs and outputs, what are all the risks that somebody might that uses it might be involved with. Mhm. And because of all these uh because we have now basically set the framework of what our product is, we can put it into context with the environment. Mhm. And we identify things that can go wrong with the product. — Mhm. — Just imagine if you plug in the power connector backwards, what could happen? It could just fry the board. It could maybe even catch fire. This would be a very serious risk. So, in our risk analysis through this method, we can identify these risks easily and take the right measures, not just any measures, because there's a mechanism inside that makes sure that we do it correctly. Just by definition. So, if we go through the process of risk analysis, we will always build better products. Not just because we always want to make better products, but because we have to. There's no way to pass it without making it better and safer. Mhm. So, basically, for exa- I'm sorry for interrupting. No, no. — uh for example, it means one of these can be like stressing your product really hard, like playing very dumb person and put and doing whatever — [snorts] — could be possible with your product and trying to figure out where your product may fail and uh how you could make it safer. That is one part of the question because one of the limits that we set or one of the definitions of a product is who uses the product. And let's imagine that the user might be a child. It might be a toy or it might be something that will stay within reach of a child like a baby monitor for example. So is there a chance that a child could touch it in a way or could damage it in some way or use like imagine a toddler nibbling on something and then you have a short circuit because saliva gets in there. Mhm. Things like these you have to think about all within the context of your product and how it's used. And with this risk analysis you have a methodical approach on how to identify these things and treat them correctly. Mhm. I have a question. You always have in mind the safety of the user. Yeah. It's always about user safety. It will also tell you about things that could damage your product. — Mhm. This will lead to other like improvements in your product because you make it more reliable. You will have less problems with your customers if the product is built better. But our first and most pressing concern is always the user safety. Mhm. Yeah I that's why I ask because basically when you find out what may go wrong with your product you can improve it and make it better to prevent these problems. But what I wanted to ask is so does it mean if someone is I don't know developing just say simple microcontroller board do they need to do this? Yes. Let's start with our first slide.

Because risk analysis is not just like oh I'm funny I tell you a crazy cool document that you should use because I think you should. It's actually a legal requirement. So if your product falls within the general product safety regulation, spoiler, it likely will. So, 99% of the products will fall under this regulation some way or another. Only — or the US or any country? In Europe. So, we're talking about the EU in that case. But, keep in mind that a lot of countries outside of the EU will also have similar laws. The GPSR is particular strict and particular precise in what it wants from you. But, I think pretty much any country has some rules about general product safety. They might have different names, but there will always be a requirements for some basic safety in a product. And this ensures that your product is not dangerous to whoever uses it in a very blatant way. I would like to point out, I think when we talked last time together, you mentioned this is some kind of recent requirements. It was not always required, correct? — Yeah. So, the general product safety regulation is the new bit because before that we had the general product safety directive. And the difference we talked about this in a in another call is directive and regulation are a bit different in how they are built up and how they are put into actual law. But, there has this change from directive to regulations. So, this is the new one. One of the major changes, there are a few in there, but one of the major changes is that now, if your product falls under this general product safety regulation, you have to have a risk analysis. Before that, only certain products had to have one. And most of these products were regulated by some other regulation on top of that. For example, uh see uh the all the directives that uh belong to the CE directives and regulations. So, when you have to CE mark your product, some of them will require you to have a risk analysis or even on risk assessment, which is just a notch up from that. So, for example, if you're building machines, then you will have to have a risk assessment. Before that, with the old regulation and you're not building a machine or no medical device or some other stuff, it was general like electronic do-dads, then you will most likely not have to have a risk analysis, but now you have to. Since when? — So, this is important to know. So, even if your product is not does not need uh CE, you will have to have a risk analysis. And what since when? Do you know when this uh this was put in effect, I think, first beginning of 2025. Okay. I think this is important because maybe uh some people don't know about this and maybe now they will be like, "Oh, maybe I should double-check this. Like, maybe we need to do that. " Yes. But, the the reason for doing it, I mean, there is a legal obligation, of course you have to. — Mhm. But, of this has some more uses where you should do it. And I would even advocate even if you would not fall under it. So, if you're not selling your product in Europe, but just only in the United States, you should still do it because it's a very valuable tool. And in case you want to enter the EU market, then you're already prepared. Okay. So, that's That would be a plus. And it doesn't cost you anything if you do the work yourself. So, why not? How do we do that? Or what do we need to do? Okay. So, first I want you to know that the risk analysis might be a scary legal document and whatever, but it's First, it's a great development tool. It tells me a lot about the product. If I have to assess someone's product and they have a risk analysis, I always want to see that first because that tells me so much about the product that I sometimes don't even have to have it in hand. Because it's usually very thorough. There are images with it. All the In a well-made risk analysis, you can see even the development cycle. Because they will document changes they have done in there. So, this is very valuable. But it's also great document, not just for develop documenting your own development, but also for all the connections between engineering and all the CEO stuff and all the C-suite. Like the people who do the big business stuff and actual engineering. It's always difficult to convey any changes that have to be made or communicate about things that will not work out as people expected. If you can show it them with the risk analysis, you will have a much better chance of communicating that correctly. And together you can make informed decisions about that. And if somebody tries to pressure you into do it that way, with the risk analysis, you can directly show them this won't work. We're not allowed to do it that way. Here's a different way. Or I found a way that follows the process of the risk analysis. And because it follows that process, I can simply show you that it is the safer or better way. Mhm. And I have to add to that in a lot of cases that I've seen, following that process leads you to a safer product, but also very often a cheaper product. Because you can often replace things that have technical solutions. We'll talk about what that is a bit later. Uh into mechanical solutions. So, why would you have like lasers keeping uh an alarm when somebody reaches into the positions where they're not supposed to be in when you can just make a cover and nobody can physically enter it. The cover is certainly cheaper. It's a very simple example, but that's how it works. If you can change something fundamental about your product that makes it safer, it might even make it cheaper to produce. Mhm. Before we continue Before I continue, I'm just curious.

So, is there some kind of template or if someone would like to start with this, how do they know like how this kind of document looks? Whoop whoop, there's a standard for that. — So, quick disclaimer, the GPSR does not require you to use a specific standard for your risk analysis. I do all my risk analysis and my risk assessments according to EN 12100. Uh that's basic safety for machinery. Because if you have to do a risk analysis and then risk assessment for machine, you have to do it according to that standard. I use that standard for everything because it's a very good standard. framework. And the only difference between a risk analysis and a risk assessment is uh one step in between. First, you analyze what the risk is there and you try to uh avoid it, but then you have to put that in numbers. And this putting in numbers is the difference between the analysis and the assessment. So, you have to apply a methodology uh according to another standard, for example, this one here, to turn it from one into the other. So, there's nothing stopping me uh from using EN 12100 as my framework for everything. It's just a better uh risk analysis that I actually have to. But it also makes sure that I don't forget things that I put it in a way that the authorities will accept. Uh it makes it's something to hold on to. So, you are sure you're not forgetting something. Mhm. So, what is actually inside of this uh document? Like, does it say like I'm just going to be I don't know. Uh like mhm these questions? Like, is there like font size or is there like topics or I have no idea what is inside. So, the way these That's something a lot of people expect if you read standards that it will tell you exactly on the point what you have to do and you follow it blindly. This is not how standards work. Standards are recipes how to do things correctly. And recipes always have like a pinch of salt, a little bit of flour, some carrots, yeah? Something like this. And it is similar to how standards work. So, what they tell you is the ingredients and how the ingredients work together and that makes up the whole recipe. So, if you're baking a cake, you know what goes into it, you know when to combine stuff of which, you know how to set the oven, and then you will at the end you will have a cake. It will not taste the same every time and by every baker it will always be a little bit different, but cake. So, it only some kind of describes what should be inside and maybe what kind of ingredients or something. Yeah. It tells you the ingredients and how you have to list them and how you interact with them. Mhm. So, it tells you Uh oh, we just go to the next slide. I think I've listed them all, the ingredients. So, but I just wanted to say that it's important and this will uh come up uh later on that a lot of the documents that you need for a CE mark are based on the risk analysis. — Mhm. Technically, if you haven't done that risk analysis first, you will have a hard time getting those other documents right. If you do it first, then you will always have an easier time.

So, let's go through the process. These are basically the ingredients that a risk analysis lists. They have to do this the same as in EN 12100. One thing it says "duly assess the risk". This is a bit of a translation error because risk can be translated in German in many words and they are differentiated, so this is just a typo. Um setting boundaries means the limits of your product. What are limits of a product? It's basically limits in physical. This is my product and this is how big it is. This is what it is intended to be used as, so the intended use, unintended use, what you're not allowed to do with it. Foreseeable misuse, that's a nice term. That's all the things you can think about people will do with your product even though it's a bad idea. So, things like "Hey, my product has two USB-C ports. What if I take a two-ended USB-C cable and plug it in both? Will it short circuit? " This is one of the foreseeable misuse things that you have to think about. So, would I now how would I go about this? The next thing is identify the hazards. One of the hazards is I just described it. You can plug a USB-C cable with both ends into the same device. What could happen now? There might be a potential for a short circuit. So, is there actually a short circuit in my construction possible? I look at my product in detail and determine can that actually happen or what will happen if people do that. So, if I have, let's say, Schottky diodes on the inputs, I have some sort of uh reverse voltage protection, I have uh current uh limiting. All these things, I also have like ESD measures in case uh the ports uh might get zapped. So, all these things that I put into my product will determine if what happens if somebody does the wrong thing with it. And I want the outcome out of that to be nothing will happen. It will just be fine. Nobody will be in danger. It might not even matter. That would be the ideal outcome. — Mhm. Also be that if I do that, it will catch fire. So, now I have to think about that. How can I prevent that from happening? And the first thing is I can't prevent people from doing dumb stuff. But what I can always do is make sure that if they do dumb stuff that I can foresee, it won't matter because the device is safely constructed. — Mhm. So, this is the the general workflow. But as you may have guessed now, we're basically we're doing loops inside that workflow. So, we're going through having the boundaries, we maybe have to adjust these boundaries. So, maybe we should uh make sure that we adapt like the whole document is a living document. — Which means you're always changing it throughout the whole development process and even afterwards. Like if your product is on the market for some time and people do dumb stuff with it, and you know of that, then you have Oh, I have to go back to the risk analysis. What happens when people do that? What do we know has happened? What can I try myself? Is there a way to prevent whatever has happened? This is what will change things in software maybe or in the new hardware revision, but I also have to document that in my risk analysis. So, it could always change over the lifetime of your product. But, I'm thinking about this. So, um you can go you can get like very wild with this. Like, you can spend months [snorts] just Yeah. creating hypothetical situations which may never happen. You could. And the thing is people do. The earlier you start with that, the more risky situations or things you have to then take measures against you can avoid uh the earlier you start. So, if I think about possible misuse scenarios early on in my design, I can avoid them in construction over the whole lifetime of development. I don't have to deal with those other later on because I already solved them. So, I go through this loop basically over and over again, see if there are risks there, take measures against them, re-evaluate, and see if they are gone. And in development, this is the exact same thing as we are doing when we develop a product to see if it's functioning. We start with a design, we evaluate if it's actually doing what we want, and then if it doesn't, then we go back another loop and uh continue our work and try to make it work with each iteration. And at some point, we also have to think about safety. And it's basically the same process and you can use this in your development cycle. Exactly as you use versioning on GitHub. You know how deep you need to go because you can go like forever deep, then you are never going to I mean, impossible scenarios that are absolutely idiotic and will never happen. Something like this. There is a there's an end to the madness. So, we'll go through the process now. Okay, and who is going to create this document? Is it the designer, developer, or because it if you really go to deep, then it can really slow down development process, no? But if you do it right, it will speed up your development process. Because you're not developing in a way where you have to then to go back like 15 steps, change something fundamental about your product because it will not pass certification at the end. Usually that's not in relation to EMC or stuff. It's more in relation of pre-product safety. So, if uh it is like short-circuit stuff. Weird uh scenarios when your product has to be plugged into another product, what happens if that product malfunctions? Yeah, stuff like that. This is more about the general safety of your product, that's why it comes from a general product safety regulation. Uh EMC concerns come at the end. But they're also in there because like immunity is one of the things. Can other devices disturb yours and make it malfunction? This also belongs in here. But there's always an end to the madness. We have a method, and this method also limits that we don't go crazy and go too deep with everything that there's you know the uh the term uh diminishing returns of investment. It's when you can spend so much more, but you only will get a little improvement. — Yes. And the methodology of the risk analysis show uh by design makes it so that you make little spending with big improvement, and at some point where the uh return on investment gets bad, this is where we stop. — Mhm. There's a defined point in there, and we will reach that very soon. — Okay.

So, let's go through that so we can like ease ourselves in. So, we have the limits of the product. Physical limits, how far, how wide, what is part of my product? Is the power supply cable connecting my thing to the power supply part of the product? Things can change drastically if I don't define these limits properly. If I have a box and there is my product and there is a cable and there's a charger with it and it's in one box and my name is on the box, this is all part of your product. Worst case. But I can also define that correctly in your manual and everywhere that you only supply this charger made by a different company with their name on there and a cable made by different company with the product because these are the official power supply and whatever, which means that in EMC they belong together and they have to be used together. Your camera switched off. I just vanished into the void. That means in regard of EMC, they belong together, they have to be tested together, but in regards of your product safety, they don't. And in the risk analysis you make that clear. This is the document all the others are based on. So, these physical limits are really important because if the if they change, they can change what tests you have to do, uh what legal obligations you have to do have to obey with all the stuff that belongs to your product or is used with the product. It's important you define that well. There are time limits, which is basically the usage, like for how long can this product be used? Is there a limit to stuff it does grease harden up after a while? Do you have to regrease things? uh do you have to like exchange oil in there? Is there something uh is there batteries that won't last for a long time? Do I have to exchange them somehow? Uh what's the guarantee or warranty for your product? All these things are defined in there. There's also user limits. Who is allowed to use your product? Is this only for specialized trained personnel or is this for little children? You're defining that. And we've already talked about this before, intended use and misuse. What is allowed to be done with your product? And you can see that these are called limits for reason. I don't have to think about scenarios that are outside of these limits. So I can't think of it that let's say the uh power supply is not part of the product. There's no cable supplied. It's just a product. USB-C is power customer supplies their own power supply for it. I can't now assess the performance of any power supply with it. It's not within the product. So in case, let's say there's an accident and the power supply is to blame with my product as long as I have constructed my product the right way to know it can deal with a faulty power supply. Like for example, it will just uh shut off and uh don't do its service if it encounters a bad power supply or something that doesn't behave according to the USB-C standards. It will just refuse to work. Just to make sure it doesn't overdraw current, for example. But if it if I don't think about that then the blame is back on me because I did not construct my product in a safe way. But this already rules out that power supply. So this is very important that we correctly define that. And time limits is if the product runs for 50 years without ever getting serviced that's not okay. In my time limits I define that this product will work for let's say 5 years. And after these 5 years somebody has to bring it in for service. Or just warranty is already after 2 years and 5 years is the expected service time. We may provide repairs or what. Up until to the 5 years, but if it's 10 years old, sorry. That's where it ends. We don't have to think about scenarios about very aging devices and things that can fail a long time in the future, way beyond these limits. And user limits is If my product is intended for professionals that have done a training course, I don't have to make it safe for children. But I also have to make sure that what is in the training course is accurate. So people are actually informed and these qualifications actually make a difference. It's not just a formality to rule out like a disclaimer or something because disclaimers don't work in product safety. You always have some duties that you have to fulfill and you can put out disclaimers all you want. If your duties are not fulfilled, they won't help. But if there's an actual difference where people have to know how to correctly use a product and they have to have training to do it like very expensive measurement equipment for example, scientific stuff. Or things that are dangerous if they are not used correctly. Then they need training. And of course, I don't have to think then about scenarios that involve people that are not allowed to use the product. So it's also putting a limit on how far we can go. And the biggest limit of course is intended use, unintended use. That's the big divider. If the intended use is listed, this is all you can do with your product. If it's not listed there, you're not allowed to do it. If you want to specify and I argue you should, some unintended use that you can think of which is really do not do this with this device. This is not what it's made for, you should list it. Yeah, do not use these shoes when it's raining outside. They are not made for that. I I actually I've seen these. So, There's a limit to that as well because um there are specifics that are that the customer can expect for a specific class of product. For example, shoes and the rain or like a customer can reasonably expect they can use their shoes in the way shoes are intended. And this is to be worn outside. I have to find this. I really I really seen this in one of the shoes when I was buying. I So, I would argue that if that is on there and you would try to sue the company for it, you will likely have a good stance because that product is like trying to make a disclaimer that is invalid. So, there's unintended use can only be stuff that is actually stuff you shouldn't expect from the product. — Yeah, like my power bank fell to water or something. No, that's not really the thing, but maybe I like a power supply like a power bank is not expected to be to work underwater or my underwater camera because it's not built for that. But if it's a underwater USB power bank for example, specifically made for diving cameras, of course I can expect it to work. Okay. I have a question. question. — makes a difference. So, uh this document uh is only available inside of the company or companies can also make it like available for everyone or you need to make it In that sentence you said the exact right thing. So, this risk analysis is part of the internal documentation if you do CE. So, if you have your CE documentation will have that. Your general product documentation it also belongs in there. This is internal documentation. You use this internally and if authorities want to see it, you have to see you have to show it to them. But, a lot of companies, especially if you're doing B2B stuff, and especially if you're building stuff like there's incomplete machines, that's a specific term within the machinery directive, but incomplete machines are made to be put into other machines and then they're building bigger uh overall machines out of them. And it's quite common for manufacturers of these incomplete machines to provide the risk analysis to their integrators, especially if they have like a more connected relationship where they build like they are the general integrator for these robots, for example. Then they will have some more data exchange, of course, how to correctly use these products and whatever and they will likely give them either the complete or like just the the last version of the risk analysis, so they know uh about risks that they have to think about or that have been solved in a way, so they make sure they don't remove that uh that way when integrating the machine. So, it makes sense to use that in your communication for advertising purposes, of course, because this shows your product is safe, but it also and that you're dealing with it professionally. But, also especially in a B2B context, you can also hand that out if you want to. You don't have to. It's your choice. But, it's like it's a big boost in transparency about the quality of our product, for example. — Mhm. Um yeah, so we had unintended and intended use, but we also have the foreseeable misuse and this is now the another differentiator. It's a way like it still is not the intended use, but it's also not like blatantly wrong. It's just a way people can mess up things. It's plugging things into the wrong ends. Super easy measure against plugging wrong things into the wrong ports is have different ports. So, only one cable fits. This is the reason you have different shaped ports on your computer. Why do you have color-coded ports on computers, especially the older ones? Because that also makes it safer and easier. The customer can then by color find the right ports. If you can, make only uh make it so that your product can only be connected in the correct way. This is safer, and this is uh one of the measures or types of measures that you can take that we go over in the actual process to apply that. This is a constructive measure. We're changing the construction of a product to make it safer.

And that brings us to the next things. We have to think about the different types of hazards. So, there are when we analyze our products, we might not see everything that can go wrong. So, it's always a good idea to have practical things. When I do assessments about products, I apart from very simple products where I can see like all the schematics and whatever, and it's just a PCB in a case, then I don't really have to touch that. But, if it's about machines, then I really like to get to that machine, look at it closely, and try to touch stuff. And get into places where I'm not supposed to go, and see if I can mess things up, or if there is there are ways the thing is constructed that would make it easy to have an accident. Classic is there's a button. I have to push that on some occasions, and I have to reach through something that is moving very close to my hand if I would push that button. That button should be there. It should be somewhere else away from all the moving bits. So, that would be a mechanical issue. There can be electrical hazards. Uh the classic is here's the cabinet where all the electronics are in there and there's a little lightning bolt symbol on there. That means electrical hazard. It warns me that there is power in there. I shouldn't touch this or open it without disconnecting power. And it will usually also say that on that There's thermal, like I can get burns. Ergonomic hazards are if I for example have to lift a box off a machine and it's just made in a way that puts a lot of strain on my back or on my arms. That it's easy to slip out and fall into the machine, stuff like that. Uh it could but it could be as simple as uh pushing uh I have to push both uh buttons at the same time to make sure I'm not reaching into the machine, but the buttons are actually so close that I can push them with one hand. — Mhm. Can still reach in. That is an ergonomic issue we have to solve. Steering is not so clear. You also call that control issue. But it's A about the uh the control mechanisms inside our machine, like how software makes sure that interlocks are done, uh motors are only activated when covers are on. Yeah. Uh everything that has to with the actual controls of a device. So, this is basically uh if in the programming something can go wrong, then this is would be a steering issue or control issue, but it can also mean the design of my device is made in a way that would lead me the user to manipulate it. So, if it's really hard to fix something that goes wrong inside a machine and I'm very eager to just use a broom handle and stick it into uh into a door interlock that always keeps triggering so I can keep that door open and just move out bits that get stuck. This is a control issue because I should not bridge that interlock, of course. I shouldn't but I'm compelled to do it. So this has to be removed. Even though the interlock is correct, it has to be there. There's still this urge for someone to make an easier job and then have an accident. So we have to get rid of those. There are a few more types of hazards in some uh standards, they go very granular into this. In others, it's a bit broader. You can choose different standards for all these uh these things. I'm a big fan of EN 12100. I think that's like for most people it's the right uh granularity. I have a question before we continue. Do you have example of this document? I just would like to you know because uh I just keep thinking right now it's everything very abstract. I would like to have something what we can touch. I don't have one prepared here but I can show you the uh the template thing but I have to uh put that so it's a template that I use internally and for my customers and they get it like my customers get this template but it might not be the right one for your product. And if we work together then I get you like a template that is a bit adapted to your use case. — Mhm. We don't need to go too deep. Just maybe we can see the content or something. Like you don't have to go through everything. Yeah, I need to uh need to find it is on online drive. You know, just to because it's very abstract. When you are talking about this for me right now, it's very abstract. Like I understand all this is important. I just have no idea how to put it into the document. Do

you see an actual sheet now? Okay, yeah. This is basically the first sheet of a risk analysis. This defines who the company is that does it, who is authorized to do all the things, identification of the thing. We have the limits of the machine. Over here, we have the standards we are using to build it, a description of the procedure. That's just like formal stuff. And then these are all the life phases of your product. We're talking about life phase in the next step, but you have to do this uh depending on different life phases. Now I understand better. the life phase of your product because risks will be different uh depending on if you're transporting the product. It will be different than when you disassemble it. Let's say there is some uh some chemical inside and you have to make sure that this doesn't get released uncontrolled. So this will be only in the disassembly. In normal uh operation, you don't bother with that. It's sealed in. So this is what makes it different, but it's basically it's a huge Excel file that you just fill out. Oh, okay, perfect. This is enough for me. Thank you. Thank you so much. — it looks usually. You don't have to do it in an Excel file. There are big programs for big money to do that. And in the end, you get a PDF. But it it's basically the same. You can use databases or whatever you're familiar with. The important bit is that all the things you need are there. And that you treat them right. That's the only important thing. — Okay.

So, these life phases, these are some the usual life phases, like transport, assembly, when you build your product, there might be risks. So, you could a risk, for example, would be somebody has to install something that is filled with a chemical. Somebody has to solder things by hand. There's a risk of burn. Uh somebody uh might need to screw things in and you could pinch your finger if you're not doing it right. If that would be a very idiotic thing to do, then uh you will not have to think about that. But, the easiest way to go about assembly risks, for example, is you have a good assembly manual that the people building your products will follow. And that will tell you put one hand here and screw with the other hand and not the other way around because then you will pinch your clothes. Uh stuff like that. Um so, if there is such an actual risk during the operation, of course, so in use, and during special things, like maintenance, cleaning, whatever, there might be different risks because you go into the device for some reason. But, also like disposal. If there anything you have to uh take special care about because it's like uh hazardous chemical, for example, uh then, of course, disposal. And there is special life phases. And these special phases are everything else that might be only happening for your product. There can always be like some special occasion. Um for startups, this is usually very important because they often have like they want to uh have a lead customer that helps with development and they already use the product in some way during development, and this is a special life phase that you have to consider. Yeah, this will be In that case, they will Startups usually make heavy use of special life phases. Okay.

Okay. So, here goes the the actual process, the loops we talked about. And this is the inner loop. So, we had like an overall loop about the product we changed fundamental things about it, how it's used, how who shouldn't use it. These are very big things. But within each of the hazards or the risks that we identified, we have to go through a process. This process is actually in the standard. So, it's called the free step process. And we always start over here. So, this is our current implementation, how our product is at this very point. That's also why versioning is very important. We have a product that now has a specific risk. And we go through this free step process always in the same order. We can't take a shortcut to some other places. We always go from top to bottom. So, what are the three steps? So, the three steps are we look at the implementation. We have that risk. First thing is inherently safe construction. Let's say there's a big wheel turning and you're not supposed to stick your finger in there. Inherent safe construction, put the cover on. You cannot physically touch that thing. Risk is completely removed. Best outcome ever. If the first measure removes the risk completely, best thing that can happen. Okay, let's say you can't uh cover that completely because you have to see if something is stuck in there and you have to see if it's turning correctly. Okay. Still inherently safe construction. Hmm, I can use a mesh over there. I can still see through it, but now I have to change a bit so it's far enough away from there so I can't stick a finger into it and still touch it. So, now my construction changes a bit to accommodate for what still could happen, but still I have used an inherently safe construction to remove that risk. Great. Okay, let's say um I can't use that because if I cover that even with a mesh, something has to go in there. The stuff that the machine is actually uh using, like the material it's processing. It has to go in there. There can't be a cover over there. Okay, we can still make an inherent safe construction if we lock people further away. But let's say for some reason people have to be close. It's all based on the construction of the very specifics of your product. That's why it's always so hard to give general answers cuz always it depends. So, the next thing is uh if I can't really if I cannot make it safe through safe construction then a technical safety function. Let's say that the control software of your product will shut off based on interlocks, based on the current draw of the motor, based on whatever. And it will shut down before things happen if it sees you approaching, for example. Yeah? So, the machine itself, the device itself, has a function that will prevent any injury. In electronics, for example, these are things like current limiting. Yeah, I know. I think I have CNC machines, small one. And it will stop if it tries to start and it feels it can't start properly, it just shut. Uh let's do a very public example. Let's get often asked, 3D printers. Yeah. Printers open frame thing, you can just touch it. How can a 3D printer just have this all open, all the moving bits, and still be safe? First step would be we have an inherently safe construction. There is a cage there's like a case around it. You can't physically touch it while it's working. If you open it the 3D printer stops immediately. This is the way usually CNC mills are done. So where it's inside like the Tormach CNCs and like or automated lathes and whatever they usually have cases. If you open that it shuts off. So that's would be an inherently safe construction because it's inside a case but you have to be able to open it. So the technical safety function would then be the interlock and to control that everything shuts down safely the moment I open that. Because I have to have access. So now our 3D printer that does not have an enclosure would do it correctly and I say correctly very specifically because not every 3D printer does that correctly. If you touch let's say a Prusa and it just hold the hot end it will just stop moving because it can feel the resistance of your finger via the current draw. So it will know if it got stuck if it got moved if it got touched by anything it will just stop. This is a technical safety function. In such a case for example with 3D printers we have especially FDM 3D printers um this goes back to the earlier days of 3D printing where we basically had to babysit the first layer and make sure that sometimes I did leveling during the first layer so it would actually stick and we have to like make little corrections here and there and have to actually be able to go in there. — Use the glue. To make it work. Yeah? So if it if I would just be locked out the printer would already had to be so reliable that I don't need to but they weren't. They just weren't at that point. And the solution to still have it accessible but also make it safe was a technical safety function. That's the current measurement. And that makes sure that you can't pinch your finger and even if the overall power that the movement happens with is so minimal that you won't get hurt. There's there are limits to power. If you go into robots and cobots and specifically you can go wild with all the power limits and thing is it's quite an interesting topic. But in that case the second step got us the solution. So what if that doesn't work? The machine or the device itself can't be uh it can't be safe just with these two. Third step would be safety equipment. This is not just personal protective equipment. This is also uh stuff like uh the light barriers for example, where things have to be accessible, you can't put a door in between, but if something crosses that line, machine will shut off. Stuff that is external to the device and will be added to the machine. So it's not actually like by definition part of the device, but it will be added to it. For example, really dumb example, you have uh a product that will only work reliable and safely with a specific power supply. It won't like work correctly with any power supply. So what do you have? Inherently safe construction, you weren't able to make it work with any supply. The technical safety function, yes, it's there, it will shut down uh if the power is wrong, but it will also then not work. Okay, but we have to make it work. Then our next thing is we have to add a very specific power supply and we have to have safety equipment with that. For example, it can it has a very special connector, only this power supply is able to plug into that device. There's no other uh no other way to power the device. And then, after the process, no matter at which point we get out of it, either the risk is still unacceptable, then we look at the current implementation and go through the whole process again and again until we reach a point where we say, "Okay, this is now fine. We have a residual We have either we have no risk anymore. That's great. Then you just mark a risk removed in your documentation, great. Or we have a residual risk. And residual risks then have to be acceptable. So, it works. There is a risk involved, but it is not high. It's very low. It will not happen very frequently, and it's easy to avoid it altogether just by the last measures, user information. And you see a word here, safety notice. You may recognize that. The safety notice is the little sheet of paper that you get with a lot of products, um, that tells you, "Do not throw this into flames. Do not short circuit. Do not do this. Do not do that. " That's where these messages come from. This is how you determine what you have to put on the sheet of paper. The last thing, the user information that is still there from a residual risk, that's the safety notice. Mhm. So, we got the three steps, yeah? Accept unacceptable risk, residual risk, and then safety notice. Yeah, my three steps. So, I try to make it inherently safe, then I use the technical Oh, okay. So, these are the three steps. — safety equipment. Okay. — And this is what comes out. The residual risk, if it's acceptable, if it's not acceptable, then we go through the whole process again. Uh, worst case, you are in a loop where you can't solve that problem, which means go back and change the fundamental construction of a product. The earlier you discover things like that, the better. The later, the more expensive these changes get. Um but once the risk is acceptable, then you inform the user about something like do not do this and that or do not load things that are not supposed to work with this thing into here, yeah. Do not manipulate this and that, yeah. But this now is very specific to the product, and this is where these little safety notices on that leaflet come from. And that also means that these informations, they are really crucial. People have to know that. And that's why it's on an extra sheet of paper always delivered with the product. The it's not by law on an extra sheet of paper. You can just also put it in the manual. It's by practical considerations because um as I said, this is a living document. There is going to assist, and if I encounter a new risk and I discover, "Oh, my measurement my measures were not right. There's a better way to do it, then I have to do it in a better way. " Or it wasn't enough. It wasn't actually a residual risk. I have to do something else. Then these will change, and I don't want to reprint the whole manual. I just want to reprint that little sheet. — Mhm. And exchange that in the packages. So, this is better from a business perspective. Okay. So

here are some of the examples. We talked about these. Like the most blatant ones, protective hoods and covers. Just put a cover on. Don't let people touch stuff they're not supposed to touch. If you're a lot of the viewers might want to develop dev kits and sell them. And this doesn't mean you have to put every dev kit into a case if you sell it. A lot of them will be in cases. For it makes sense, but we also have to consider how things are actually used. And if it's dev kit and I'm supposed to plug stuff into it, the first thing I will do is remove that uh that cover like I removed myself here. And get access to the actual bits where I want to measure, connect stuff. So, if I would use now a case or whatever as a protective device, it would fail. That is not in line with the intended use. So, I will get into the next step. The technical safety function. So, okay, if people are supposed to touch that thing, then I should put current limiting in so uh they won't get a shock, for example, or I make sure that no um lines that actually have dangerous voltages are touchable. Uh so, in my construction, I change things to make sure that even though I will sell this without a case, or people will use it without a case even though it's it comes with it, it's still safe. Mhm. So, you can see how this step this process leads you to get rid of expensive components and add other maybe less expensive components to your bomb, but that will overall make your product safer. And it's always in context with how it's actually used. So, I don't have to uh think about crazy uses of a dev kit if somebody dips it in boiling water and then it may short circuit because that is not the intended use. But if it is laying on my desk, and if I probe it with an oscilloscope, it shouldn't be possible that I put 230 volts by accident into my oscilloscope. It just shouldn't work by design. I shouldn't be able to touch it uh and shock myself. This is all inherent safe construction. So, inherent safe construction doesn't always mean just covers on everything. It also means electrical engineering. So, light grids, interlocks, these are all uh safety equipment. Unless the interlock is really tightly integrated with your uh with the control system of your device, then it might be uh taking the safety function. And hazard symbols and operating instructions, these are information. These are stuff that is at the end, at the very end. I can't just tell people, "Well, don't do that. " The The risk is only there if you do that. Don't do that. If you can do it, you have to take measures. If and if it's reasonable to expect people to do it. So, you can't just sell a device without any uh safety measures and just tell people, "Don't do this. Don't do that. Don't do anything with it. Just don't use it at all. Just buy it. " And and that's all. No, you have to make sure that it's actually usable in a safe way. So, when it performs its intended use, it's actually safe. You can't just warn and also you can't warn against things that are not there. I've seen a lot of safety notices where they basically copy-pasted to everything they warn against everything. I said, "No, you are not allowed to warn against things that are actually not there. " You know why? No. Because if you are, let's say, afraid of an electrical shock in a situation where you can't get a shock, you might oversee other hazards. So, you might only be aware that oh, where my hands touch, I'm not I have to be aware that there are there's a risk of electrical shock here where there isn't and you're not watching your feet where there's nothing. — So, always only warn against things that are actually there. And also, why put a million stickers on there if you don't have to? That's the other thing. These hazard symbols like the the rest of the wrist what we have here, safety notice user information that own means stuff that is in the manual, stuff that is on the safety notice, and also in some cases uh things that you have to put on the device themselves. Uh for example, if you have uh let's say something with an antenna. There's an SMA port on there. Sometimes you see a little ESD sensitivity sticker on there. That's for that reason. You don't want people to touch that A, but you also don't want uh to test that specific port for ESD safety because it won't survive. It's an antenna connector. It's not supposed to. There's usually an antenna on there. When we are talking about these uh you know, sometimes there are these kind of weird uh instructions like do not uh dry your underwear in microwave or do not put your animal or pets into microwave or Yeah. There's uh a lot of the funny examples. Uh there's a lot of fake examples out there. Yeah? That's one thing. The other thing is a lot of them come from uh from usually older uh lawsuits where they had somebody do that and then they got sued and then they had to have a settlement. So, now they're basically ruling that out because now they knew that is a foreseeable misuse. We should cover that. And there's like the the more American way would be to warn specific against all these things, but the European way is, well, you know of this misuse. So, go back through your process. Check your limits. Check your user limits. Make sure that this is not uh used for anything it's not intended for, define those, make sure that if somebody does it, because now you know it's a foreseeable misuse, what could happen worst case, make sure that uh won't work or that it won't have a bad outcome. And if that's not if your process doesn't allow for that, safety notice, user information. This is where this partially comes from. Yeah, sometimes they can be ridiculous. These are like not very common. It's much more common that a lot of important information on there is left out. That's more common. So, uh in my in sometimes there's a funny story to this. Uh but what I usually tend and I sometimes try to investigate that if I find specific places where there are warning signs for very specific things, there's usually an interesting story behind that. There's always like when you can see a specific uh like there's a corner of a of a house and there are it's like marked so you can ideally see it, you you'll pretty much notice somebody drove into there. There's usually like a funny story behind that. We have an intersection in my hometown that used to have eight stop signs. It's now six. — [snorts] — And the story is people don't obey the stop sign, uh get into the intersection and have an accident. That's why there are eight stop signs. It looks funny, but it's nobody knows if the eight really helped. It still happens. There's a famous uh bridge that people uh constantly drive into. There's even a website just dedicated to that. So, these things happen and then you think about how to solve these issues. — Mhm. How to solve it in a reasonable way. If they're completely outrageous, then it might be not uh not a way of your construction. It might be a communications issue. So your manual might not be up to spec. Okay, so uh these hazard symbols also come from that. So if you have to put a specific warning on a specific part of your product, uh this whole process tells you which symbol and what has to be underneath. Like there's the lightning bolt there. Uh deadly risk of electric shock, for example. That's 230 V AC inside. If you open it, then you could touch the thing. So there will be likely some notice like uh always uh disconnect power before opening the device. And in some case, disconnect power, wait for at least X minutes before opening the device. Yeah, the old TV come from. You remember the old TV? Mhm. Yeah, exactly. Oh, yeah. Exactly. Don't I If somebody uh wants to play with old CRTs, they can hold a charge for a very long time. So be aware of that. There might still be a way to shock yourself. Always discharge any capillary tubes before going in there. And uh they usually also have some of these warnings. Be aware that the whole CE process and start started in 1995. So if you have stuff that is before that, it might not have any safety warnings at all, even though the risks are there. So be the All this legislation came from experience, basically, because things happened. And we don't want people to get hurt anymore. This is where this all started. Uh another example of protective measures, of course, personal protective equipment, goggles, gloves, whatever is needed. Uh one thing that uh startups uh often ask is can I just uh tell people to always use like all the protective equipment and uh like no, this is like one of the disclaimers only if it's actually helpful. You can't just tell people to have a bulletproof vest on at all times and like a bomb squad suit. It would be safe in there, but they could still not do their work with the device. It still has to be reasonable in the framework that they actually use it. And you can see how that all limits how crazy you can go with that. There's

There's uh It's going to the process context. The the you've seen in my template example how big that all can go. Like the different life phases and stuff. And I usually have like three things filled out there and I just copy paste when I need more. This is about 20 pages or so. If your risk analysis and there's like when I take over a project or whatever, I ask people to already have done a risk analysis. Or with all the products, usually it's please show me the risk analysis first and we go from there. And sometimes you go, yeah, of course we have one. Here it is and it's one A4 sheet of paper. And I can already tell this will be not a lot not enough because as you've seen all the data you're required to fill in doesn't fit on a single sheet of paper. Um Mine are usually like 20 to 30 pages depending on the complexity of the product. But risk analysis can be very simple if your product is very simple. So it might just be like one or two risks per life phase of your product. That's it. And if you have a very complex machine that has to interactions with a lot of different components and different configurations. Like modular products have usually a very intricate risk analysis because all the different configurations have to be taken into account. Um they can go uh pretty wild. That's usually where you like involve an expert with that, but you can do that all on your own. This doesn't have to have any cost attached to it. If you just put in the work yourself, and you should because you as the designer or the developer of your product are the best person to do it because you know your product the best. And sometimes the solutions are for an engineer a little change. And who else could know that little change, but the person who built it? So, you can also take the most advantage of that overall thing if you start early in the design process with the risk analysis, you're not developing in the wrong direction where there's no way back or no way to make it safe. You already know about the things that will happen and avoid them from the beginning. So, you can save a lot of time in the process, and also in case things are going in a way you don't like to, this is an easy way to tell your boss, "We can't do it that way because this will not fly. This will not be legal. But if we do it my way, here is an easy solution for that. We just have to take a step back. " People don't like change in direction in projects, but sometimes you have to uh go back sooner than later. If you do changes at the very end, they will always be more expensive than doing them early on. Mhm. So, I have a tricky question. So, what if you don't cover something, and then something bad will happen because you because of you didn't really count on this situation, is it going to be problem that you don't have it in the specification or what are exactly the, you know, consequences of not really having it in this document? We're bordering now the liability. So, if I not think about this specific hazard, but it was obvious that we can have maybe just left it out because I don't want to deal with that. That would be gross negligence. That would be very bad. If it's something that could happen under some circumstances, but it wasn't very like foreseeable. Like it Okay, it's possible. We now know that it happened. Then we can take measures after the fact. As I said, it's a living document. We just go back. We analyze what happened. We find out why that was possible to happen. And then we go through the free-step process. I say, "Okay, is there something we can change about the product fundamentally to completely remove that risk? Or is there something that we can do in software, for example, to make sure that this doesn't happen again? Or is it as simple as putting it uh into the user manual to avoid that? That's why it's a living document. You update that. You have some versioning in there. So, you know, you can see the process, and you can show authorities that you did take care. So, even if you Let's say you didn't do it 100% and we have to be like very up front with that. If you let 100 people do the risk analysis for the same product, you will get 100 different documents. They are not exactly the same, but they will have the same outcome if they're done correctly, a safe product. Some things might be changed in one might be addressed in one way or in another, but the outcome will always be, hopefully, a safe product. And if we uh if we know of a way that, for example, like the like a competitor did it, then we should implement the better way of these two. And uh this also relates to standards because what standards actually are they a reflection of the current state of the art. And if solving an a safety issue in a specific way becomes the industry norm, things that like all the manufacturers of kettles will always put a thermal fuse in there. So it can't have a runaway heating element. The thermal fuse is now the standard. Now if you look at the standards that apply to household equipment, you will find that thermal fuse in there. Because it became the best solution people could find. Everybody did it and that's why it's now the standard and now you're required to have it. This is how standards evolve. If there is a better solution, the standard will change over time. They're usually like a lot slower than the actual uh actual technical developments. So they're usually a bit behind. Uh but eventually they usually catch up to how things are built. And if you or your competitor finds a better way, then do it in the better way. So I have have All works together. So what I wanted to ask basically, if we don't think about improving our product, uh how this document can be used? Like is it used uh when you go through certification or is it used when someone sue your company because something happened or when exactly this document would be used? The answer is yes to all of these. So it's useful in your development as we've discussed before. It's required for your product compliance. So if your product falls under the GPSR which knowing our audience, it will likely will. Uh you have to have it. — really check it? Yeah, if authorities want to see it, yes, of course. Um So in your CE compliance, of course, you can't have a valid CE mark without it. It's part of your technical documentation. It's actually a core part. In case you build specific classes of products like machine for ex- a machine for example, then you have to have the bigger version of it. And, uh, what will authorities actually check if there's an accident or something happens? Or what is the documents that, uh, competitors would like to see if they try to sue you? These are the documents that prove you have taken the right steps, you took care, you did the right thing, you documented all the changes that you've done, you have done your market surveillance, which is also an obligation under CE. So, if you know something bad has happened with that product or could potentially happen. Now we know it, now we address it. We make sure that the next version is safer. We give out an update to our customers, whatever. We, uh, in some cases, for example, uh, companies have to sell uh, send out updated user manuals that have the new changes in them. Stuff like that. These are all measures that you then have to take if you know of something that could be safer or that's like it triggered some sort of action. Sometimes authorities demand it, but it's always good to be proactive about it. And tell, "Okay, dear authorities, we know of these issues. We have already addressed them. Here's our documentation. Just so you know, in case this gets reported, we already did the right work. " So, if you have all these in order, this is exactly what you need uh, for your liability. You show that you have done the work. It's the same as in your declaration of conformity for EMC and whatever. It says, "I have done the tests. I know that my product, uh, is okay. " And if they think, "Mm, I'm not so sure about that," then you can show them the receipts. Show them the test report. And this risk analysis is basically like the test report for the overall safety of your product. Mhm. Do really — that you've done the process. All companies do this, like Chinese companies selling the You have to ask those companies then. But uh does it mean they can still sell the products even if they don't have it? Technically, no, because the uh there are requirements to put stuff on the market. And for example, GPSR article 5 only safe products. Proof that your product is safe, you have to have a risk analysis. It's in there. If you if your product is not safe and there's no risk analysis, it wasn't legal on the market. But it's correct to You can put on the CE mark on your product and sell it, but if it's not valid, it doesn't matter. So, it's it was just a forgery. If you put out a declaration of conformity and it doesn't list the right uh regulations that apply, it's invalid. If you didn't sign it, it's invalid. If it if you didn't do the tests and couldn't back that claim up, it's invalid. It's all the same. Can someone check it somehow or how does it work? — Of course, authorities just have to ask for it and then they can check everything in there. It's it's one of the things that you never hear in public because who's proud of that? Um but uh if you look at for example, the safety gate report, it's uh there's the normal safety gate and there's the consumer safety gate. This is basically an EU platform where people uh can uh report dangerous products. And if something shows up there, then it has already been determined that it's unsafe because before that the report happens, the authorities will go to the uh responsible person for that product and ask for specific documents and for proof. And if they don't get it, then uh they will uh issue some measures which is like recalls. Uh the product gets revoked, whatever. And that can be uh sometimes it's just update to the documents or whatever, but if there is an actual product recall, it will get listed there. Everybody can see that, of course. This is where you can get a list of recalls that are currently happening, for example. I get a weekly report where all the new products are there, but this does only happen if somebody did not provide Mhm. the data. If they If somebody says, "Oh, your product got reported and we now want to say see the data for it and you just provide them to them, they look through it and say, "Okay, so fun. " Mhm. And then But someone has to report them. Yeah, um there are multiple ways that uh you might get in contact with authorities. There's uh the like random checks. They can just at random uh like check one of your companies whenever they feel like it. Doesn't matter. They can do that at any point in time. Much more likely is something has happened like an accident or something and then there's an investigation on why that accident happened. And usually uh either the client themselves could report it or more likely insurance companies would like to know about the actual safety of the product because if they can prove that the product was unsafe, then they don't have to pay you or don't want to pay if it's your product. Um so they will look at that and of course authorities uh will look into that as well if something happened, but it could also be that a competitor uh might report your product. So if you're dealing with the same space in the same general space and they know your product isn't safe or doesn't adhere to the regulations, they would like to That's an easy way to get rid of a competitor. So is it anonymous or like No, it's not. You have to ID yourself. Um usually like each uh European uh state has a way of online ID that you do with your phone and it proves that you're you and you have to log in with that to report products. You can also do that on a national level. This is different in every country. In mine it's just an email to the ministry. In others they have a website for that. So it's very different, but the EU way basically is over Safety Gate you report a product. And then they will automatically give that to the right authorities. Mhm. Okay, I'm in this country. I bought it in this country, and they will then contact those authorities. And if they then deem this product unsafe or would like to have to it removed from the market, then all the other authorities get automatically informed about that. Mhm. But then only the institution knows who you are. The company they don't know. They just about that. It depends on how the case is evolving. Okay. It could be that there's a lawsuit involved as well. So Yeah, okay. I was just curious, you know, if just go around anonymously and like report random things. — report random people for nothing. That's not how it works. Yeah, you can't do that. So and usually companies will not just go around and get competitors into trouble if they don't have a really good reason for that. — That's what I wanted to know. Like if the competitor will know that the other competitor In some cases it will be quite obvious which competitor was. And you will likely then go the other way around and say, "Okay, you think my product is not compliant. Show your compliance first. " And this is where it gets ugly. So you won't do that without a very good reason. Mhm. But there are like countless products. If you look at Safety Gate, there's like incredible how many products get reported every day. And yeah, it's a lot of this comes from customs, for example. So if there is an illegal product uh going into customs and they find this is not allowed on the market, then they will automatically report that, of course. A lot of cars are usually in there because like the bigger manufacturers like every manufacturer has the obligation to report their own products. Then, go back to the risk analysis, find the ways to make it safer, document that, do the changes, show the authorities, "Okay, we did the work. We tested this. Now, it's safe. " And they go, "Okay, that's good enough. Go back to market. " — they find out there is problem, they have to report themselves? You're uh every manufacturer is uh has the duty to report their products if they know of it. But most will uh usually try to avoid that altogether or uh have issue fixes before that gets public. — Mhm. So, before something happens, they already rolled out the fix. — Mhm. And sometimes they then do the report like after and say, "Okay, this was an issue. We already fixed it. " to show that they did the actual work. Mhm. Okay, we should continue so it's not too long. Yeah, there's a lot of adjacent topics. But yeah, this is great for your liability and you have to have it actually. So, the role of the risk assessment, we touched on that. It's the basis for all the other documents that you need for CE compliance. It will give the safety notices, the safety instructions on the little sheets. These are all come from that. It will tell you exactly what they have to put into the user manual. It will give you a hazard labeling like all these danger symbols that you put on your product or in the manual. And of course, it is an integral part of the technical documentation. And one last thing with that, the technical documentation usually has some requirements of what has to be in there. A big part of these requirements are already fulfilled by the risk analysis. Like the limits of the product, the identification and stuff. So, you can just take that, copy-paste, that's it. So, this This is already it's an actual like people are thinking, "Oh, it's just one of many documents. " But, it's the most central document in my opinion. To your whole technical documentation. It already fulfills a lot of the requirements for that overall thing. So, if you start with that, you've already done a massive amount of work. We currently have Get Standard running, which is like our group certification program for open source hardware. And the participants uh just recently got like their initial reports and the templates for the risk analysis. And we also help them start to do that. Is this the last slide? Oh, yeah. Yeah, this is the last one. Okay. Can you show your website? And so what do you do? And also to show how people can contact you. Just Uh just No. Okay. Just make sure that I would like to say risk analysis is only one of the things what you do. We did the previous video about certification. It was a really good one. Uh so, this is my website. We uh you can see the website now? Yes. Okay

so under services, we have a lot of things. One of these is risk analysis. Um I usually do these mostly for bigger projects, bigger companies because I'm a big advocate of do this yourself. Mhm. Cuz you know the product the best. This is where you can save a lot of money, especially if you're like an independent developer. So, this is something that you do alongside the development. When you have come to a point or when you get stuck and you need some help, then you can get help from us. But this is something that you should at least start and try to do yourself. Uh you will do this for every product over and over again and it's more of a tool than it's an obligation basically. I use this as a tool myself all the time. So this is basically telling you all the key aspects of it. Uh we have that on the website and if you get stuck, you can just easily book a consultation call to get help. You can also of course outsource that completely, but since it's a lot of writing work and it's built by the hour, then of course uh doing it yourself and getting it checked is the cheaper option. — Mhm. So I'm all for transparency there. There's no point in me uh in getting more work for me. I want to get more people on the market, not uh having to write more risk analysis because it takes a lot of time. Um yeah. So one of the things we just did, I told you before, currently gets men around zero is running and people are now doing the risk analysis and having a call before that, so we explain exactly what they have to do. So these applications are closed. Yeah, because it's round zero now and once that is done, we know how many spots we can uh provide for the next round and then they will open up again. So if you want to get informed about that, we have a newsletter and you just subscribe to the newsletter and you will know uh first hand when it is. We also have a Discord where you get all the the regulatory news and all the stuff that's going on with us if I don't vanish from existence. And uh so it doesn't really matter where you are in the process, a risk analysis is always the right thing. Mhm. So you will have to have it eventually. The earlier you start, the easier it will be for you. Where are you located? Uh I'm located in Austria. So in a little town just south of Vienna and um actually uh just shortly before opening uh our new workshop, which means we have a physical location where people can also come. We usually do most of the stuff online just in consultation calls and uh by exchanging files and whatever. Uh but if people prefer, they will in the future have the ability to just come here and do everything in person. We had a few requested and I locally like within uh the country I also uh go to companies, but of course like it's you have to pay for people to travel. So uh online calls have been like the main way and it's the most popular way of course. Mhm. — Cuz on demand and easy. Uh so but does it mean you do this service all around the world for everyone who would who need this certification for I don't know Europe or something like that, yeah? Yeah, so it's focused on Europe. So we're focusing really on CE, getting the CE mark. This is for Europe and all the other markets that accept CE because it's not just the EU countries, it's also a bit more like uh the United Kingdom also accepts CE next to the UKCA mark. You don't have to have UKCA there, you can also go on to market with CE, which is nice. Uh some other countries like Norway and Switzerland, they also accept CE. So it makes sense to do that, it's a big market and we basically everyone who wants to enter that market they can uh they can have the services. The only requirement is I can do my uh consultations in uh English and in German. I don't any other languages. So if you No Chinese. Yeah, if you speak those languages, hooray, we can help you, but if you don't, then we're going to have a hard time with translating. Uh what is your email address or how they contact you? Oh, you can just So, easiest thing to get the news, newsletter, join the Discord. There's a Discord with over 100 people where we exchange all the things and you get like all the regulatory news and whatever. And otherwise, it's just like over here, hello@z-wave. com. — Okay. And we will be at some events. But I don't know when that video will go live, so maybe these are already passed after that. But we're regularly at events doing CE talks. Uh if you want to have a talk at your event, you can also contact us. So, there's always a possibility to get the info somehow. Yeah, I know we met at Embedded World. Exactly. We at Embedded World, for example, yeah. Okay, thank you so much, Clemens. If If anyone has any questions about this CE or risk analysis, leave them in the comments and we can make another video. Yeah. I hope this is of help to the people and if you need help, we're always here to help. Thank you. That's all for this video. I hope it was helpful. If you would like to learn more about electronics and board design, check out our online courses. You will find everything important there, from basic board design up to advanced board design and high-speed PCB layout. We have courses in Altium, Cadence, KiCad, and also courses covering many different topics, for example, FPGA, EMC measurements, and so on. Visit our website at federa. com. Thank you very much for watching and don't forget to leave your comments. See you in the next video. Bye.