PRRC Mini Masterclass Featuring Ronald Boumans

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my marketing rudeness. And oh, wait! I do have one other thing that I wanted to show you, so I don't know if you know, Team Prc. Is having their annual summit this year in Rome, and everyone knows that I love Rome, while little do a lot of people know that there are a ton of Caravaggio paintings in Rome. So I'm organizing this unofficial team. Prc, walking tour on October 23, rd at 4 o'clock. It's free. It's me my dog will not be there and gonna see a bunch of Caravaggio paintings and then go to dinner, and that'll be a huge fun time. that is, that is, I swear the last of my announcements.

any details about the team Prc, meeting? Just message me. how's everyone today? Ronald?

Yeah, I'm fine. Yeah.

Everybody give a hands up in the air if you're okay. Yeah. welcome. Nice to see so many new faces. Looks like we have a good lot of people, 56 participants participating from all over the world. I am thrilled to introduce Ronald. Who's gonna walk us through? What it means to be a Prc. And some other fun stuff. Hit it.

Yep, okay. Let's see. Can I share? Yep, I'm sharing. And now you should see my slides, did I?

Now. Yeah, now we're seeing your slides. Thank you.

Okay, good. Right? Okay. Well, thank you. For this opportunity to to speak about the Poc. I'll do it as a sort of Mini, Mister Mini, master class which you're going to see are the slides the 1st group of 3 slides No. 3. Come on the 1st section of my training. That I'm now developing is an on demand training. So you can do that. In a few weeks it will be online available. So you can do the Poc training. This is the 1st module of it.

Great.

And it's about the poc concept. I cannot see if there are comments coming in. I cannot see that now. Sean, if if.

I'm gonna take care of the comments. I'll let you know if there's anything you need to answer. Watching the chat and the QA. Function. If you have questions for Ronald, please use the Q&A function. It makes it easier for me to distill that from the chatter. Thanks.

Okay? Good. So I think it's it's a unique role. It requires a unique approach. And but let's start with with disclaimer Article 15 does not provide a lot of information. So what you're getting is my opinion and and you can use it at your own risk. Basically, that's that's what this disclaimer is about. I'll talk about the legal background of the Prc provide present you with a pragmatic interpretation. Some practical implementation steps you can do and and there is. There is training. If you want to do. There are options for more training. So this is me with my Boc face. But normally I'm a very nice guy. So

I've worked with medical devices since I graduated as industrial designer in 1987 and and then I stayed with medical devices ever since in my career. In 2,002, I became an inspector for the Dutch competent authority. So there I saw a lot of things that can go wrong and it. It was fun until I yeah. I sort of lost the the real perspective. Medical devices were things that killed people and mutilated them for life. That was my daily practice. So if you ever come and and meet an inspector who is quite seasoned. Be aware that they are facing these problematic devices every day, and and they will will treat you in a similar way. So just

be careful in in managing their expectations. They they will be careful. They will be yeah, they have a certain perspective on devices. So after 11 years, I started working as a consultant for Imurgo, and in 2022, I started my own company and 2023, I realized I still didn't have a lot of work with startups. So I co-founded Munich Medtech, which is specializing in startups and bringing startups to investors. I have a motto. A good pilot can land a plane in storm, and an excellent pilot knows how to fly around by the weather, and that's what we're going to do today. I'm going to help you to navigate

bad radar. I'll start with the conclusion. So if you have to leave earlier, you have already the conclusions, and you know what I'm what I will be talking about. Mdr. Ifdr. Do not specify the role clearly. guidance is scarce and does not add clarity. Now that, I think is an opportunity, it's not a problem. It's an opportunity. As long as we stay within the definitions of the within the borders of Article 15. We can do anything with the Prc. And that's what I'm going to do. So stay with me. It's going to be fun. Poc should assist all levels in the company in being in compliance. So it's not limited to the, to the.

to the the Regulatory Affairs Department. I'll introduce Van Campen's law on the thermodynamics of of information. He had his Phd. Presented his Phd. Thesis this week. and it was that was very interesting, as I've last minute integrated that into my presentation an organization can only function function if it has access and uses the adequate information. So don't limit, ignore, or suppress information. If you do that, you will lose energy in in your organization. Basically, he quantified Karma, especially bad karma. So as Poc be an advisor, being a communicator, and don't be the compliance police. It's a different thing. Don't do that. That's not your role

as a Poc spot issues early, proactively, and so that the company, not you. The company, can intervene before those issues become a problem or even a crisis. And of course you should become a super. Prc. now the Poc concept. Let's look at that. What what does it mean? First, st let me introduce the term phantom legislation. Hmm. In 2,001. The the qualified person was introduced in in the Medicinal Product Directive. That was a great success. It's you have. You need to have a qualified person for a product release. And you need to have one for for pharmacovigilance that that worked well. These are highly special specialized people, pharmacists.

Yeah, that worked very well, and the lawmaker wanted to copy that. But the nature of devices is fundamentally different. and so they had to change that. So in in 2,008, I saw this qualified person concept for medical devices, and I and and I was still working as an inspector. and the whole group we we all went like, no, that's not going to work. So yeah, it was changed. But that that concept does. The shadow remained. Some traces remained. That's phantom legislation, right? Like something is amputated, you feel still can still feel pain in an amputated limp.

That's phantom pain. This is phantom legislation, so you can. So some of these things don't deserve a purpose, and it may introduce unnecessary risks like being your name being in you domain. If if someone on the Internet goes mad, they can go come after the the Prc. It's fully unjustified. But it is a risk. Your name is there? That's not even for qualified persons. Right? Qualified persons are not publicly known. Now, the so that so that that's that's phantom legislation. I'll have a few more about in in this presentation. It's it's that's a bit of fun. Now, the main concept of Article 15.

The lawmaker wanted to have at least one person with adequate understanding within an organization that means there must be relevant knowledge, relevant expert expertise. For that person. The role can be outsourced. You can appoint multiple Pocs. And if the Poc and the Poc shall not suffer from doing the job properly, come to that later in more detail. So that's basically the concept. Do your job properly. And and that's it. It doesn't tell us what the Poc should be doing. It's not really there, right? Is the Poc responsible? And and again, phantom legislation. I mean, is the Poc responsible? Well, there's an r in it, right? The 1st R person responsible for. So why should Poc not be responsible? Well, if you look at Article 10, especially the section about quality management system.

you see that the quality management system, addresses responsibilities of the management and the management represents the legal person. There's nothing about Bsc. In Article 10. If you look at Article 15. It says that you that the Poc. Should be responsible for regulatory compliance and Article 15, 3 limits that further, to responsible for ensuring certain things happen right, certain things are done. So you're responsible for ensuring certain things done their internal processes. So the Psc. Is doing an internal job is not. The Psc. Is not going outside right? No specific external responsibility for the Prc. Make sure you communicate that to management because it makes them feel more at ease when you're talking with the Prc. Because

that's what the Poc. Does speak with management. Speak with the rest of the organization, but not externally. and the legislation. We can see similar roles or dissimilar. The responsible person for cosmetics, the qualified person for Medicinal Products Data Protection Officer, right? And the data protection protection officer is that's interesting because they need to inform and advise the data controller, and they must monitor compliance. And that's almost the same thing as what the Prc should be doing. So yeah, it's it's a very close role. Now, as a Poc, your opinion matters. you really have to understand how that works

should be clear for the Prc. And for management, that there is a legal weight to the opinion of the Prc. So if you're a Poc, be careful when you issue an opinion or not right, be very careful in doing that, because it has legal weight. At the moment you give that opinion, that formal opinion as a Prc. Management should take care of that, and should should really address that opinion because. if things go wrong, the authorities may want to know who knew what and when and then it's very important. When did the Poc say something about that? Could management have acted earlier? So and if you if you look at how that works in in practice

something goes wrong. The authorities start an investigation. Did Psc. Know? If not, why, if he knew. Did he report? If not, why, if management received the report. did they act? If not, why, if management acted and it didn't work, it was not effective. Why? Etc. So it's very important that you that you keep a a good get to keep records and and and so that you can give evidence of what happened. Because if things get wrong, be sure that if management gets into trouble the Poc is thrown under the bus. I've seen several of these cases already. Pocs reach out to me if they get into trouble, it happens

people happy in the job, and from one day to the other they were in the middle of their 1st nightmare. So make sure you protect yourself by proper record keeping. Yes, and the Poc. Opinion can have consequences, so be careful with it. Don't hesitate if it's necessary, but be just. Don't issue too many opinions too easy. Now as Poc. You must have relevant knowledge and expertise. if you look at Article 15, one, it says, relevant study not necessary at an EU university or an audit training as recognized by the competent authority. The Mdcg. Has disfigure that into that a non-EU study must be recognized by the competent authority and says nothing about other training.

They have completely the wrong end of the stick, and even after team poc, Made them aware of that. They they kept They kept it in the guidance. I don't know why, but this is what it is, and and I've never. I've I've seen a lot of Prcs in America and Japan with all kind of very interesting. Very good university degrees. That have not been recognized by the competent authority. So don't worry about that. You must have at least one year of relevant experience, or if that's not sufficient, at least 4 years of relevant experience. If you work for an authorized representative, and they represent multiple clients and they have Ivds and medical devices. Then the Poc must have experience in both. That's something to be aware of.

And yeah, be careful. With that. Custom made devices. You must have at least 2 years of relevant experience. No university degrees that that's not necessary. But 2 years of relevant experience and relevant if you have been working for a dental lab, you cannot be the poc for an orthopedic shoemaker, for example, it must be relevant for the branch you're working in years of experience. it's never. It's it's not specified anywhere. But I think you can carefully can can consider that as calendar years and not fte years, because otherwise it's almost impossible to calculate that now justify that in writing, and make sure that there is written evidence during an audit

For some reason auditors find it very important that you have this evidence. So if you show them your Linkedin profile. No, no, no, that's That self decoration or your Cv, that self decoration doesn't work. You need to have something else you need to. For example, let a Hr sign off, or whatever and for most note for bodies. That's enough. Right then. Okay, then these boxes are checked, and they don't go into what the Poc is actually doing. So it's. I think. not, for boys need a bit of education regarding what they have to expect, what they can expect from the Prc. You can outsource the Prc. For micro and small enterprises. They can do that.

There are some criteria and the definition of a small and medium sized micro small and medium sized organizations. There's a guidance document for it. If you, if you are working in that situation is relevant, use that guidance document because it's very clear. It's it's a huge document. But it's it's very clear in defining that role. Authorized representatives can outsource anyway? And but if you outsource, then the poc must be permanently and continuously available. and what does that mean? That's not clear, the Mcg said. Well, that's permanent and continuous. That's not does not help.

I think, that you should see this as no contractual limit limitations on the availability. So if you have, if you're an outsourced poc. it should not be that in the contract. It says that you are limited to like 4 h per month, or something. And anything above that. You can't work. You should have arrangement for that for extra time. That's necessary. It should be in the in the contract. and if something happens on Friday morning nobody can expect you for that week to be working for 40 h. That's just not practical as a Poc. You you should be allowed to go on vacation to have short time sick leave. Of course, if you're not available for a longer period, things need to be changed. But

as poc, I I work as an outsource Poc and I go on vacation, and even with my phone turned off. And it's fine. It works. If you grow as a company, you have 2 years to adapt to the new situation again. But again, that's in the in the guidance document. You can work with multiple Prcs, and even the smallest company should consider appointing an extra poc, because a Poc can leave on short notice, or whatever happens, I mean, they they can be run over by a bus? you never know. And then then you are without a poc, and that that can be a problem. If you have multiple Pocs, you can separate tasks.

and do as you think is is smart, right for products versus quality, various device families, different size. different levels of expertise, all kind of things. It whatever is best for the organization put in writing that must be there. It must be available within your organization. You may specify in unit. It's not a mandatory field. I recommend doing it because that gives some information to the authorities. and if you do that in a smart way. It demonstrates that you understand what's going on. If you just copy Article 15, 3. So all the lines there, you sometimes see that in unit, then you're sort of signaling that you're not really understanding what's going on. It's that's don't do that.

If you specify something you make sure it's consistent with what's in the rest of the organization that should be one on one copies. Now, as a Poc, what's your role within an organization? I think you should be an expert on on the regulations that Staff can approach. If they have questions they know they should be, be, should should understand that they they have to go to the. They can go to the Prc, especially when it's about compliance. As a Poc, you can help upper management to stay in compliance. So yeah, they are the the guide, the pilot piloting company, through bad weather or around bad weather.

as a PC. You should be authorized to inform upper management. after being asked so it should be a logical thing to do, to be asked as a as a Poc to to be part of meetings, management meetings, not all, not all the time, but you should be there. and you should also be allowed to inform management on your own initiative. so the door should always be open to you. You have to arrange that now. The Psc. Is not a competent authority staff. They don't work for them. or for note for body and a Poc is also not someone who decides on major actions. The Poc is not the person to call for

a recall. If something goes wrong, they can advise management to call for a recall, but they cannot do that themselves fed a situation where a competent authority reached out to to Psc. And they say, you must now recall the device. And that was like, what? Yeah, I had to step in there to provide a little bit of guidance as a Poc. You don't have to inform others outside the organization. You stay within the organization, and if you communicate that clearly to upper management. It's sort of relief for them. They know that you, as a Poc, are limited in what you can do and what you should do as a Poc. You shall suffer no disadvantage. Now, how does that work? Well, it only covers the manufacture of the the manufacturer. Poc. If you're working for an authorized representative. You have to cover that specifically. So in your appointment letter, make sure that you refer to Article 15 5, that that also applies to you. Then you have exactly the same cover.

It's for internal external Prcs. If they fulfill their duties properly, so do your job, and only your job. Don't go outside your job as Poc. You cannot be helped. Be liable for defective devices, because the Poc is working within the organization and the the the legal manufacturer can be held liable, but not the Prcs. Now, Member, there are some Member States of fines for the Pocs. In the law. But that appears to be intended for grossly negligent Prcs, but it's not written in that way. I assume they will be paying attention to that. So if you, if you have a situation and you're looking looking away from that, yes, you're running a risk

again. That brings us back to who knew what and when now, is the Poc liable or responsible? I think the Poc is responsible for the compliance within an organization not outside. It's within an organization. The Psc. Is not externally liable for the compliance or for the safety of devices. Right? That sounds so logical. But the general public may not understand that. And that's that's a that couldn't be can be a risk for for the Prc. Now to understand the term liability and versus responsibility. I have this picture. It's

fire, safety drill demonstration. In the 18 nineties you see 40 fire, 14 firemen holding a safety net. and they are each responsible for holding their part of the rope stretching that safety net. They're each responsible for that. They're not responsible for what the guys next to them are doing. That's their job responsible for that. Now Bottom left as a person. We look on his back. He's the commander. If something goes wrong and the person jumping gets seriously injured. He's liable. So there you have the difference. So they're holding the net. The other guy is just waiting and hopefully go. Everything goes well. He's liable.

He organized this, but the others they have to do their job properly. So 14 pocs of one picture in the 18 nineties. Van Kempen's law in thermodynamics of information. It's a very short thing, but it's it's interesting to to see that as a concept he treats information energy as something as very similar concept and with energy. You have increasing entropy when energy gets lost. Right? So and you can apply something same, something similar on information. So information like energy can be transferred. You can transfer energy, can transfer information, you can use it.

But over time it uses it loses usefulness just like energy. It sort of gets lost it. You have an increase of increasing entropy with energy, and if you have, if you're losing information, it means your chaos increases. Now, accumulating energy means less entropy. Accumulating information means reducing chaos. If you, if you want in a car to reach a specific definition, definition, you need specific. correct timely information. So optimal information means minimal chaos and minimal chaos. And that means minimal loss of energy within an organization. And the same happens with the Prc. The Poc. Should be there to concentrate information and make sure it's

at the right place at the right moment, and then you need to do something with it as manager. It's very important to have that idea. And if you start suppressing information, things go wrong. So what does the Poc actually do. Well, look at the data protection regulation, inform and advice. Basically, that's what the Poc does based on information collected within the organization. Make sure as a Psc that you help all staff, all levels to understand requirements. You need to verify compliance. You can use sampling for that. But so it's just like a note for body. You don't have to do everything. You don't have to sign off check every document, every document, every technical documentation, every fictions report. It's not not necessary

as a pse. You should spend time on networking within an organization that's the nice bit drinking a lot of coffee. As a Poc, you may be able to inform upper management about issues that didn't pass the filter of middle management. We all know how middle management works right. They have their own agenda. They they have, they have to that. That's that's their job. They all they need to filter information. but they need to filter the right information, and as pse. if you're there, and if they, if middle management knows that you can go around them and inform upper management, it helps them to keep that filter regarding compliance. A bit more sensitive.

Now, this big difference between a Prc. And an auditor. If something is not written down. It may still have happened for the Prc. Right? We also all know what happens with an audit. If it's not written down, it didn't happen. But not if you're a Poc. I think if you do your job better as a Poc, you're noticed, you're recognized, and just by being there you make others more aware and more motivated. To be compliant. you would have met. And again, we have some phantom legislation here. Full name name of the Poc is made available in you demand? I mean, that's a Gdpr issue, right or not. Now, there is a

exemption within the Gdpr. For personal data that is necessary to be published for reasons of compliance. And this is this is how the European Commission has straighten this this terrible band in in what they've done. The name of the Psc. Is listed onyx. 6. And on Article 31, 30, dash one requires all data. All that data in Udemn article 31, 7 requires all data from that 1st article to be made public, and therefore it's for a reason of compliance that the name of the Prc. Is there? It's it's complete bollocks, of course. But it is what it is. I mean, if they should have said in Article 31 dash 7 all data from

should be in. Your demand should be on the public side. Except for the name of the Poc. It would would have been fine. it would have made no difference. But now it's there. the name is publicly available, and that means there's a risk for Pocs to be targeted by citizens who suffer from a failing device or think they suffered from that. It serves no purpose. It's a risk for Prcs. I think if if we have a clear case that a Poc is targeted, publicly targeted, all Psc. Should should demand to be removed from a unit, they can remain in place, but they should ask to be removed from unimed. or ask their company to change the name of the Prc. In unit to well, to to hire this external Prc, it's a very nice guy. He's French. He's called Pierre, Rc.

And if all, if they all do the same thing, it's a clear signal at the same day. It's a clear signal to to the European Commission that they should change this. Otherwise, if if we if we start doing this individually. You you get them after you individually. But yeah, we have to wait for a moment that unfortunately, we have to wait for a moment. That goes wrong. and we can expect this goes wrong. This is, this is a an accident in in waiting. Unfortunately. So how do you appoint a Poc. I think the role of the Poc should be defined before appointing the Poc. Which some very often see. It's it's less and less now, but especially in the beginning someone suitable was told, oh, yeah, you you can be the Poc. And now, sure, yes, yes. What does the poc do? Huh?

I know that because it happened to me. I've been in that exactly that situation. It meant that I had to figure out what happened. And hey, Prester, here's the result. I'm now trading. Prcs. there's a lesson here for your career. don't consider problems as problems. Consider this as opportunities and and look at. Look at me. Make sure that if you appoint a Poc. That all these items in Article 53 are addressed. If you're working for an authorized representative is Article 11 3 that you that you need to, you need to figure that out. and the other training I the next module of the training I go deeper into that.

Make sure as Psc. You have a adequate legal cover. It should you should, you should have a really good cover, because you can get in all kind of situations. Now, regarding the location. If you look at location in in Article 15, it's it's not, or it's very ambiguously specified. It says that you must have a Poc within the organization. Right now, if you look at the guidance document. the the 1st version of the guidance document by the Nscg. It says that if the manufacturer is based in the EU, the Psc. Must also be in the EU, and if the manufacturer is based outside the EU. The Pse must also be based outside the EU

in the EU manufacturer, based in Finland, can use a Poc from Portugal and outside. I mean. it goes all over the place in art, in Revision one. They have added that the Psc. Should be geographically close to the location where the economic economic operator is based. Now, Article 15 says that the Poc should be within the organization and organization is a social concept, it's not geographical. Again, we're talking phantom legislation here. We have situations where, for example, in Switzerland. Now you have huge companies in Switzerland with the very legal manufacturer is just a few miles down the road.

In in in Germany, France, or or or or Italy, or Liechtenstein. and so where should the Poc be right? Or if you're working for let's say a European manufacturer, legal manufacturer based in Europe and their production, including sterilization, takes place in, let's say, China, you cannot be the peer you can. As a Poc. You cannot be based in China. If you follow Poc guidance. Just think about it completely ridiculous. So I think what notified body should be looking is looking for is is the poc, where the action is the same thing for authorized representatives. do you? Sometimes you have these large organizations, large corporations, their head offices, let's let's say, in in the Us.

And all the regulatory work is done there and then they have a corner in one of their marketing offices somewhere in Europe. And yeah, there's the Poc doing nothing. I mean there's not no information regarding The the authorized representation is going there because everything is done at the office at the head office in in the us. So it's completely bollocks. You should have a Prc. Locally where the action is. of course, try to be at the main address of the manufacturer, the authorized. But you can go somewhere else if if you can justify that, there are multiple locations. what's the most critical? Consider multiple Bscs. But whatever you do justify it.

That goes something wrong. The poc and whistleblowers. Now, sometimes the poc is seen as sort of institutionalized whistleblower. That's wrong, because the Poc is not supposed to speak outside of the organization. A whistleblower does and why does the visible blow do that? Because they they see a problematic situation. They want to raise an alarm about that, but they're not feeling hurt. And it's not good for the for the reputation of your company. If there is a whistleblower. so someone wants to blow that whistle. You can stop them. But It's quite a step right. I've I've been in that situation myself it. You don't do that unless you've really really forced to do that. So

if you have a good poc. then that should be a sort of person to go to person. If you feel you have to to raise a flag as to raise an alarm, and that may prevent someone going outside. And so if you have the function of the Poc well organized within your organization. there's less fear for whistle blowers. As a as a Poc. You have to manage expectations. Expectations of your management and and your own expectations. What can you do as a Poc. What's your what's your power? It's quite limited. Actually, if you have listened carefully. make sure your tasks are defined.

What do you need to do, and how and when and how often? make sure. You understand, if this is a part-time role or full-time. do you have enough time for the role? Most Pocs do it as a part-time role. So they work somewhere in regulatory, and then they then they have a few hours to to perform the role of the Prc that must be enough. You must have enough time to do that. Who do you report to? If you have multiple locations? Very often I see Poc struggling with multiple locations because there's no butcher to travel, no time to travel. You should. You should arrange that in in in your appointment in appointment letter?

If you have, do you have certain tools and templates? Can you? Change them as needed? Right? if you are working as a Poc. You need to assess, start the the starting position of the company, so prepare for that, and and make sure you can. You can do that assessment. Now, of course, make sure that you have access to location and staff and staff has access to you, and can speak to you safely. and also address fictions, reporting because fictions reporting is very important for for the, for for confirming compliance, confirming the continued compliance of the device.

May I ask a question.

Yes.

One of the audience members asked a question, and there's another comment that I wanted to interject. He says I'm recently being prepared by my manager to be his backup. Prc, we're having discussions on how to document the Prc. Tasks that I perform documentation tasks. He is suggesting that we can add the role of Prc. In each procedure that requires review of Prc. Or under umbrella ensuring compliance. Well, I think that if we create a Prc. Procedure that writes all the process the Prc. Needs to check in accordance to relatable and applicable guidance will be better. Kindly advise.

Yes. yes, yes, make make sure you have a good procedure that covers everything, and also makes clear that you cannot do everything. You should be sampling. Compliance is performed by others or other roles. Yet you may have multiple roles in which you are also compiling technical documentation. but checking the technical documentation as a Prc, it's a different role. It's a different thing. So make sure it's in the in the procedure. I don't want to be too commercial. But if you, if you do, the training you get templates. Among the templates is the Poc procedure. So there you have it.

There you go. Yeah,

Question.

As a comment notified body requires authorized representative to provide evidence of liability. Insurance, which, you know, sort of brings up the difference between authorized representative in Prc. I don't know if you.

One end.

Touch on that at all. But yeah. is there any liability insurance required for Prcs.

There's that's a big discussion within team. Poc, I don't think you need. You need one.

Oh!

Because it's covered by the it's it's the liability is covered by liability insurance for product liability. And your organization should have should cover the legal issues. By an insurance policy that covers that. So that you have a lawyer to to represent you. Even if you are up against your own management. it should be there, and officers and directors policy that that's covered, that that should be there? But yeah, because that's and and if you're working externally, then you have your

then you you have to cover as a as a consultant and make sure that your insurance company knows that you're working as a Prc.

Hmm good advice.

Yep, I have a my my insurance company says that I need to specify my hours. So I I keep records of my hours. And as a Poc, because they're covered, for that is higher and and there it's. It's a very simple thing to do, but it's yeah. I I do that so that those hours are covered with an extra policy. It's it's got. I I need to submit that every 3 months it's not not a big deal. Now do not sign off for compliance. Right? If you look at documents, they they procedure being released. The document or product. That's not the task. The Poc. They don't release their. They don't release products. They don't do that

procedure released by the management representative. You have your quality management system for certain. documents products. There, there's procedure procedure for that. As a PC. You can check if that's done. Accordingly, to the, to, the, to the requirements and in line with the Mdr. Not the quality management system. Mdr. as a PC. You may have multiple roles. So you. You're working maybe as a manager and also as a Poc. If you're signing off on something, make sure that it's clear who signs off. Are you, the manager, signing off the Prc. Or what? Make sure that's clear. If you have multiple roles

and the Poc. Half of your personality would say, no, don't sign carefully consider signing. Because your other part of your personality. Because, yeah, you know, right? You cannot unknow what the Poc knows, and you're the same person. But yeah, still, you can sign when I'm working for a company. As an external Psc is an outsource pse. I also work as a consultant. So very often we have discussions. And then what does the Prc. Think? And sometimes I know where that answer would go. And I say, well, who are you asking the Prc. Or the consultant? Then they say, Okay, 1st question, let's 1st ask the consultant. So then the consultant gives his opinion. And what would the Poc say? Well, hmm, not

and and that that's very clear. So then they know, okay, do we need to ask the Poc for for his opinion or not as a Poc. If I if I want to give an opinion, I'll do it. But if it's not strictly necessary. I don't do it, and it makes it possible for them to to navigate the the fog of war in non-compliance. A bit better and competent authorities are aware that a. No company, no product is fully 100% compliant. They are aware of that. So as a Prc. You will see noncompliances everywhere. Do you need to raise the flag? Maybe not.

So be careful with that. Now conclusions again. the role is not specifically not specified clearly, but it's an opportunity. And I hope you've seen that I've taken that opportunity to make the role to Prc interesting and useful and added, adding value to an organization as a Psu, you should assist all levels in the company in being compliant. I hope I demonstrate that you can do that. An organization can only function if it has access to adequate information, so don't limit or suppress information. Be an advisor and a communicator. Don't be the compliance police. and as a Prc spot issues early and proactively, so Comp company can intervene before they become a problem, and of course be a super. Psc.

now. So this what you saw is the shorter version of the 1st module of 3 about role to Psc module 2 is about setting up the role it addresses how you, as a Psc. You can manage expectation for management and staff, and how management can make sure the Poc is performing module 3 is about handling issues. So if things go wrong, if you see issues happening, what can you do? And what should you not do? And how can you help the communication? Please send me a note. If you want to have a heads up when this is available. business training. You also get templates 7 templates organizing that that role and

and there is a sort of lifelong guarantee. If you, if you run into pro problems. preach out because I want to have, because if I if my my training can be improved I use that. I use the experience of other Prcs to to to write about the scenarios. and oh, yeah. Oh, yes. In this the there's a Prc masterclass. The day before the Prc. Summit in Rome. So it's on the 20 second of October. if there's enough interest, so if you want to be there, send me a note. So then we'll dive to a deep dive full day. It's the same content as the as the training, but it's a it's a full day we go much deeper into it. There's a lot of interaction.

I've done this this masterclass several times. Now, typically all Pcs. There are completely exhausted at the end at the end of the day. But, I get a lot of good feedback once they have recovered. So let me know if you want to be there, then I I can put you on the list.

Yeah, so.

And if you have a Poc problem, just reach out. Okay. be super. PC, and here are my contact details.

Please reach out to Ronald if you wanna request a copy of the presentation, he will let you know if he's gonna share it.

Yes, yes, of course, of course you can.

Yeah. So reach out to him for presentation. Reach out to him for more details on on the training, right in the chat. If you want to go on the Caravaggio tour and I hope to see you in Rome. Now we are going to have the AI minute with Mark, if he's here. I hope he's here. Mark, are you here?

Are you going to repeat a question.

Oh, yeah. There was an important question.

Yeah.

The important question was, in a startup where you wear many hats? How.

No, no, no, no, no! The the question that for for.

Oh, repeat the question right? Oh, the question to submit! So if you want to be included in today's Linkedin article, I would like you to submit aside from recruitment purposes, what are the benefits of being a Prc. And why would anybody want to do it? something like that? Sorry.

And then there was a question about a startup.

Yeah, wearing many hats. How do you? Oh, yeah.

Oh, just just do it. I mean within a startup. what I I've I've worked with several startups where I have a contract for 1 h per month, and so as a deputy poc, so I keep the poc within a startup on a tight leash. So they they need to report to me. And I I check what they're doing. That helps a lot. As a startup until you're actually in deep into the certification. You don't need a Prc. So that that you but at at least you make sure you have contact with someone who could be a Prc and that helps a lot. But if you're if you're working in a startup with a lot of heads, yes, you have to manage that like. You have to manage all the other hats, and it helps if you, if you can, make a clear distinction of what is the role of the poc and what not.

because if something goes wrong, you need to have proper records, and that's that's crucial.

Great. I want to turn it over to Mark for our AI minute. He's going to discuss something really important that came up this week with Chat Gpt and Llms. Which is, when do you upload a document? And when do you cut and paste the whole thing in Hi, mark.

Hey? I like to. This is my conversation. I have over and over and over with people who like to use Lms to summarize documents and do stuff which is one of the best things they're good for. But most people don't really understand how to do that. Well, so my name is Mark. I lead the engineering team at Marcus engineering. So when you upload a file to chat, gpt what it does, is it it? It creates like a database like a card index of the content of the file. It doesn't actually look at the whole thing. It can't see the whole thing. It can only look up snippets. It can only search through a file and give you like a 1 paragraph response. And so

that that means it has a bunch of limitations when you upload a file so you can think of it the. And so if you paste a file into chat, Gpt, you give it everything, the whole content. And you kind of force it to read that. And so you can think about it like like it's flipping on a light in a room. So when you paste the whole file, you know, you light up everything, you see everything, you have all the context, and when you give it a file to upload. It's kind of like pointing around with a flashlight. It can find information. It can look for stuff. It can search for things, but it can't get you the whole context. It can't make decisions or interpretations of the whole thing all at once.

So a bunch of examples about when you should upload and when should copy paste for files. So one of the easy ones is, if you need to find definitions in a file, upload it. Search it. It's really good at that. If you want to find all the references for something in a file, upload it, search it. It'll do a good job at that. If you want to find all the extract, all the references say, hey, in this procedure? Where's all the places we talk about nonconforming product. That's really good. Use case or find this section that talks about this one thing if you're trying to look for something in it. But vice versa. If you're trying to do something that

looks the whole document, you really need to copy paste. So summarize the main updates. That's not a thing you can search for. That's something you have to know and understand and look. Explain how privacy is addressed. That's not something where you can go, and you know, look for privacy in 5 sections. That's context thought process that's woven through the whole document, you know. Compare the review requirements. Compare, you know, the deep thinking about the documents. That's stuff that you really have to read and understand the documents to know. And you know, drafting a plain language summary, you can't search a document, for where's the plain language? Summary? The Iso standard writers were not so kind as to include a translation from Iso to English. You have to read and understand it yourself to make that interpretation.

And so I like to have an example of when this goes good and bad, so provide a brief summary of the critical specifications, regular targets for this document. This is when I was working on recently the essential performance of electrocardiograms. And so if we're looking at this. This is a example where we want to paste the document because we want to consider the whole thing. And so if you don't do that, if you just upload it. I put in this prompt. I asked it, and I reviewed it because I was very familiar with this. I was able to evaluate both outputs. So when we upload it missed references to standards, they make a bunch of critical references to standards that you need to comply with. You need to use.

They missed a bunch of requirements of test conditions. If you summarized it, gave it to your engineering team. Talk to people you'd miss. Oh, hey, this testing needs to be done like this. This testing needs to be done like this. All those details that are are not summarized nicely for you. It. This requires a bunch of Ifu sections. If you summarize this and you're like, Oh, I'll just put in this information. It didn't identify. Oh, hey! I need this. I need this. I need this because that wasn't something that I found. Well, just summarizing it. But we copy paste it. You can list all the references to standards. It got all the things, includes all the testing conditions in addition to the performance specs, and includes those required. Ifu certifications. Ifu sections, you know those items that you might miss if you didn't read the whole document and understand the whole content.

And you know the the last thing is like, well, it sounds like pasting is always better. I mean, the answer is, yes, pasting is always better. The problem is chatgpt. You can only paste something like 12 to 20 pages in Standard Chatgpt. You can't paste 200 pages things like that. There are other tools which is a topic for another day that you can paste up to 1,500 pages, thousands of pages, many, many documents to look over. But that'll be a story for another AI minute in a future week. So.

Thank you, mark for the AI minute, if you like the AI minute, please put a thumbs up, and I want to thank Ronald again, and all of you for your time. It's great to see so many people here today. I believe we had, like 70 people. Please help us spread the word. If you find these valuable. If you have constructive criticism from me on how we can make these, oh, a little bit more interactive, we're working on it. So if you have suggestions. comments feel free to share them with me. I'm thin skinned, but not that thin skinned. So the I appreciate all your feedback and all your participation, and remember, support each other. If you see each other on Linkedin, drop a like doesn't cost you anything. Thanks. Have a great day. Take care, everyone.

Take care, everyone.

Bye.

Thank you.

Thank you.

Mine.

I am.

Thanks.

Bye, bye.