Smart RAQA Compliance for a Shifting Future | Marcus Emne

Aloha. Let's see, I'm gonna…

Can I change my background? Yeah.

Okay, Frazian. He's the co-host.

Yep.

Okay, so you're gonna promote the people, right?

Yes.

Okay, so I don't need to worry about that. Thank you.

Of course. Bye.

Bye. Hey everybody, welcome. you should be promoted in a minute. If you don't want to be promoted, just decline. And we are here today with our guest speaker on Hawaiian Shirt Gonzo Friday, if anybody remembers that from the 1980s. Marcus Emney from, Huden is CEO. Excuse me.

Honolulu.

from Honolulu, right? No, he's not in Honolulu, nor am I, although you might think so. And, we are here to talk about… Working smarter, not harder, right? Yeah?

Yeah.

And, hi everyone. Let's… let's take a moment to say hello. Carrie, say hello to everyone.

Hello, Gonzo Friday.

Do you remember that?

Of course I remember that! But I did… we wore Jimmy Jams as ladies.

Oh, okay. I don't know what Jimmy jams are, but…

That's okay. Must have been a Colorado thing. Do we have…

to watch an episode of Magnum PI this afternoon?

I… yes, that's… Still on.

Right.

Leo, where's your Hawaiian shirt, Andre?

Ty doesn't go with a Hawaiian shirt.

We have at least.

Palm trees on it. Michelle should have her Hawaiian shirt on, or Florida.

shirt on.

How's it?

She's got the beach scene on, at least.

So…

You miss the conversation.

Oh, it's… it's Hawaiian Shirt Day, Michelle.

She messed up.

In case you didn't get the memo. So, I just wanted to take a minute to, talk about two things. One, I still need 40 more respondents for my AI user survey, and so what I want you to do is, if you work with other people, I want you to share this link with them and be like, look, you better do this. survey, because Sean is going to get mad at you, and I really could use help with this, so I'm going to drop that into the chat once I figure out where it is. And in the meantime, I'd like to take a moment. Yesterday, we did an MLV webinar, With, more than 400 registrants on, the topic of human factors.

in silico and real-world evidence, and we had 4 amazing speakers on, and sort of the regulatory component of that. Daniel, I don't know if you know Jay Vaishenev from, Cannon, Medical Informatics in California, but she was, she's former FDA. Oh, okay. And, she, sort of set the whole thing up, you know? what the opportunities are, with, you know, the human factors in silico and real-world evidence. Three sort of niche-within-niche areas, and so I thought of the idea of marrying the three of them together. It's a really good webinar.

And if you would like the replay, I'm happy to share that. replay and password directness, which is segue into next week's speaker, is going to be one of the human factors, directors from Claramed is gonna be coming and talking about human factors. I've interviewed her. It is fascinating to talk to Kay Sim. She loves human factors, she, has a lot to say, and I learn so much every time I speak to her. So… If you are interested in a really dynamic session on human factors, please, join us next week, right here. Okay. And, it will be really good, I promise.

Let's see… and I will be live from Portugal.

Okay, great. But you said you had a link that you wanted to send me?

Oh, yeah, I'm gonna drop that in the chat once I get my act together. In the meantime, I'm going to introduce today's speaker, Marcus, who I've known for a couple of years now. Hard to believe that so much time has gone by. We keep getting younger and younger, and or less mature, depending on how you look at it. And, he, has a company that he started a number of years ago, and has been working with… I will… A lot of stuff around regulations. market surveillance, and developing tools for… for doing this. I'm not gonna say any more about him, I'm gonna let him,

show you what he's been working on, but it's some neat stuff, so… Pay attention, folks. Marcus?

Thank you so much for the introduction, Sean. I was… I was about to lean back here. It's afternoon in Sweden, you know, I was like, yeah, Sean can do this.

Can you talk a little louder, or turn the volume?

I'll, get closer to the mic, and I turn it up a little bit. Okay, can you hear me better now?

Much better, thank you.

Okay, very good. I will, speak out and articulate well. It's a funny word, articulate. Shouldn't be much easier to pronounce. So, as you can hear, I'm not from the US, I'm based in Sweden, even though I live in the US, but that's a long time ago. So, today, we're gonna talk… just as Sean introduced, we're gonna talk about… compliance, regulations, and, AI, the future of regulatory work, and, just to… Before I start sharing my screen, just a few words about who I am and what Hooden is.

So… Hooden was founded… 2000… 16? Or even before that, but that was more as a, you know, garage project, where we really wanted to solve a couple of technical things before we decided to take this commercially. So we did that around 2017, and back then, it was like a Swiss Army knife. It could do a lot of things, but nothing really good. So, at 2019, I met with a lady. Called Annette Hogren. She's, she was hired by the European Commission to, to write the, the new regulations, medical device regulation and IVDR. To write some of those parts, and she told me about this, and also explained to me

That, you know, this is gonna put a lot of pressure on companies. Getting into the European, market. And also legacy products that's gonna be… you know, in transition from MDD to MDR. And the weird thing is that in the same time, my oldest daughter, who at that time was doing both handball, I know that's not a big thing in the US, but that's more or less when you play soccer, but you don't use your Beats? And… and also, gymnastics, and that is not a very good thing for your knees in combination. So she had an issue with her knee and needed surgery, and both of the titanium screws were contaminated, and she needed a lot of surgeries, and she's fine now, but that was a, you know, a very…

Tense period, and… I felt like my responsibility to try to prevent that this could happen to any other kid or any other family to have 2 years of surgery and recovery and so forth. And healthcare just didn't know what to do when it comes to patient safety and reporting Reporting adverse events. So I was kind of… left… Struck in the middle, and… I met with Annette, she told me about this, and I felt, hmm, this is where we could help. we're gonna move from being the Swiss Army knife, towards life sciences, and do what we can in order to…

Help companies in that? industry… to understand regulations, To cope with the regulations and to reach compliance? Because if they do, That will Spill over to patient safety. So that's my… I'd say the soft part of our business model, and the reason why we're Where… where are… where we are. So that's the short background about why we even exist and why we operate within the life science industry. And, over the recent year. We, we did a little bit of a PIVO, Because we started out with surveillance.

Trying to help companies, monitor literature, adverse events. Clinical trials and so forth, everything that is required for post-market surveillance, which is a tricky thing to do. But what we realized During that journey. Was that it's really hard… we started early, it was really hard to interpret what the regulations was really saying, because there wasn't any predicates. The guidances were, somewhat half-baked, or missing. And there was a lot of noise in the market with… With, with the demands on rewriting the, the regulation per se. So, and also, we recognize that a lot of companies simply didn't understand the regulations or the guidances that were published.

Completely, or they just pushed them. So we felt like, maybe… maybe we should help the… our clients to first understand what game they are in. And get their arms around this giant hairball of regulations, guidances, standards, and position papers, and everything you need to know in order to know what to do. To reach compliance. And that's what I'm gonna talk about today. So that was my quick intro, somewhat quick, and now we're gonna jump into this webinar. And hopefully, it's gonna be, It's gonna be, interactive so that… oh, that looks weird. Okay. I do not really know what you guys can see on your screen now.

We are seeing.

A cloud.

a slide with clouds, I think, that's moving.

Yeah.

From applicable lists to living compliance, AI in the future of regulatory work.

Or, yeah.

Yeah, well… Somewhat. It's… it's close enough.

Okay, very good. Then, then let's do this, like this. So, from applicable list of, living compliance, AI, and the future of regulatory work. So, applicable list of requirements. I hope you're all familiar with that. That would be your… your list of… Applicable regulations, applicable guidances. and applicable standards, and also position papers from notified bodies, if you're on the European market. we're… I'm mainly gonna talk about the European market, but we also address North America, which would be… federal regulations and laws, but also state. state regulations or legal counterparts on state level, and Canada.

So those are the geographies we cover right now. Because geography, of course, you know, is something you have to factor in when it comes to regulations. It's rather important. So, What Hooden is, just to, you know. So you get your arms around who we are. It's a regulatory intelligence tool for audit supporting compliance. It's not a regulatory intelligence tool in the manner that you just monitor regulatory updates and so on. It actually builds your applicable list of regulations, and also lists all the legal counterparts in the other markets that you're in. That's the current version of Hooden. Please try it out, there's a free

14-day free trial, with no limitations, all you can… Eat buffet, really, but for 14 days.

I'm gonna interrupt him here, since he's not saying this. It's only, like, 139 euros a month, or something like that. It's… this is not one of those platforms that's, like… you know, oh, here's your quarter million dollar contract, for your team, but rather, very affordable. So, yeah, sorry he didn't say that, I did.

Thank you very much. I'm too… I'm too shy. Okay, so… but we're not going to talk too much about hoodin today. We're talking… we're gonna talk about where we're heading with Huden. And… This chalkboard, tells us, that, every, every team, or all of you, you would be obliged under MDR or IVD, are Act 10-9, FDA, QMSR, or an ISO, 13485, Chapter 413, you need to maintain a justified, version-controlled and up-to-date list of applicable requirements, which would be the regulations, standards. GSPRs, which would be part of the MDR regulation, and the relevant guidance is applied.

By auditors in practice. That's really the demand, and… and this is not optional, it's the backbone of compliance, the way I see it. And also very… I'd say crucial for operations. If you have this. This would be your… your map to El Dorado, really, because then you have everything you need to explain to operations why They need to change something. So it's kind of operational traceability as well. I don't know, maybe that's an odd expression. But this is… this is the rule, the set of rule that we're under, and that we simply need to follow in order to sell.

our products, either on the European market or similar demands for the U.S. market. Correct me if I'm wrong. So… but what does… what does this really mean? I'm just setting the scene here. We're gonna jump into the more fancier part, in just a few minutes. So, what you need to do is obviously learn to maintain a list of applicable requirements, which will be the regulations, standards, guidances, ESPRs. And it must be justified. You need to tell why each item is included or excluded, so applicable or non-applicable. It could be conditional as well. And the third one is that it must be up-to-date, and now it's starting to get a little bit tricky.

So it has to be continuously monitored, and it cannot be a one-off exercise. And then, it must be version controlled. Every change log, decision, and rational is recorded. So adding these on top of each other, we start to realize that, yeah, this is a giant air ball, and it's not very easy to maneuver. So, that's the what question. Now, when? Do we need this? Well, you need it for MDR and IBDR, Article 10-9, Annex 2-4. It's a mandatory thing for CE marking on devices, or IBDs. So, end of story there, really. But you also need it for FDA QMSR 21CFR820, And it applies for all MedTech products marketed in the U.S.

We have the same thing in ISO. And it applies at design, market entry, and throughout the entire product lifecycle, really. So, now we have what and when. And when is it checked? So, it will be during audits. It will be during the technical documentation review. It will be… For the submissions… But also, during operations, what I meant earlier, so that… You know, without the correct list, it will… Just turn into whack-a-mole firefighting. Because you really need it, and it will make your life easier if you have it on the details required, and use it in your day-to-day operations.

So, here comes, like, a poll. And… I would really like to, you to engage in this poll and use the chat in Zoom. And… Reply, with… How you manage your applicable requirements today, and there's a couple of options to make this easier. So, either you use Excel and spreadsheets. or you use this… you run these operations in your QMS system. You have a dedicated tool or platform for it. You have consultants doing it for you, and then it ends up in some shape. We don't. or others. Let's, let's, leave this for a minute, and use the chat, and pick your choice.

And Sean, who is amazingly fast in math, he will calculate this, and Build a spreadsheet dashboard and provide graphs and stuff. On this, in just a minute. He's, he said that. No. You don't have to, Sean. But we can try to figure out a winner.

I-I will figure it out, well… As soon as everybody answers. In the meantime, does anybody have any comments? Peanut Gallery? Anyone want to add anything to this?

Y-yeah, this is Dan. I think this is very interesting and obviously very important. However, I think that as a solution provides part of the solution, but the problem that I have seen in the industry and I've seen it on a consistent basis, it's the lack of… or the lack of the ability to make the right interpretation of the regulations. So you have the book. You have the regulation in front of you. And you either over-interpret or under-interpret. And the problem that I've seen in the industry is that you try to over-interpret when you don't understand it well, so you try to be as conservative as you can, and you under-interpret when you really have no idea of what you're doing, and then you end up trying to do the minimum, because…

You know, either cost constraints, or… we just don't want to have you know, we… we just want the minimum. So, I think this is… this is a good thing. But I think that, you know, the emphasis still… Has to be that once you have that book available to you, whether you call it the guidance, or the requirement, or… The worksheet, whatever it is, you have to make the right interpretation. And that's a problem, in my opinion.

That's a… that's a very good comment. Because if we think about this stepwise, first you need to know what really applies, and just there. companies struggle with knowing what applies, because we're not talking only MDR here, we're talking about all the cross-domain regulations as well. And, you know, if you sell your product on multiple markets, you have, first of all, then the industry-specific regulations, then we have the cross-domain regulation, and then it starts to spread out to a huge number of guidances, and rulebooks, and then standards on top of that, and then you need to interpret it. I think people get a little bit tired.

At the end of that process. And… Go for either of the options you say here. There's… There's one thing that really helps here. And that is what we've seen and learned now, is that you need someone who challenges you. And… and make… becomes advocacy, and knows both your product and the regulation, or the legal document, or the standard, that It's… That's the current focus. And that's spelled a really well-trained GPT. And it works, because then you get challenged. But it's still a tricky thing. I'm not saying it solves everything.

you have to decide… I think you have to have a regulatory strategy that sets the framework on which way you go, and you should have that dialogue with your auditor as well.

So, I challenge that a little bit. You can use GP, but you have to confirm your results. Because you do need the technical expert to confirm what's going on, because I've seen some very challenging results out of GPT, or whatever you're going to be using. And I've been using it to try to formulate this Because that's what I do, is standards, regulations, laws, guidances, and… at the beginning of projects as design inputs all the time for my clients. It's one of the first things I do on every project.

I don't think you challenged it. I think you filled it in with something that is very important, and that is that the human expertise and the human final decision, it was matters. Then what brings you to the best decision? That's… that's what I'm trying to talk about now. I don't think there… Hopefully, it will be a platform or a solution that will take that away. Entirely, but it should be designed so that you get the support presented in a way that really helps you go to the best possible decision, if you get what I mean.

So I put the final results up. There was… there was one more number two, show… Yeah. the… the QMS then was the, the most voted for, with 7, 6 Excels, and then the other ones, they're in, they're in the chat. But, yeah, that's our… that's our poll. So, mostly ones and twos.

Yeah, that's what I hoped for. I would have been a little bit scared if I was the winner. Which I'm glad for. So, great, we understand that it's used in… or we know then, then, from here, that mainly… and this is what I get most of the time. Most often, I would say Excel spreadsheets would be the clear winner. I'm glad to hear that you use this in your QMS system, because that's… Even better, then you don't have a… Because it should end up there, sooner or later. Very good. So, let's get going, unless there's any other comments or questions regarding this. And feel free to interrupt at… interrupt at any time.

Okay. I'll, take that silence as a go-ahead. So… When requirements aren't fully captured. I'm just gonna give you a few examples of things that has happened that I… I wouldn't… I… I don't claim that having a… Applicable list of requirements is the sole reason to why this happens. But if you read behind the lines in the public announcement and what happens. it's probably part of the reason. Here's a Swedish company called Exvivo. And they had a CE approval for hardware. And, but they're, perfusion solution was delayed, 6 to 12 months.

And… and they had a, well, they had a lot of problems with that, patients waiting, market taxes lost, and the stock price went down with 35% in… in 24 hours. These are the real case costs and harms that you will get if you I'd say… Don't do this correctly, or end up in that situation where you overdo it or underestimate, what it should cover. Then we have Hologic, also a Swedish company. They got an FDA warning letter, recall producers. procedures. And, Class 1 recall, hundreds of injuries, lawsuit, and stock fell 33%. And then this one you probably know about, the Philips.

Respironics, and this one is more interesting, I think, because this is a reason of a cross-domain regulation. So they had global recalls after the foam degradation. failure to anticipate the chemical and biocompability requirements, which is REACH and biocompability regulation in Europe. And they had billions in cost, and they had patient harm, and truly a reputational damage. I'm just tossing these up. Just to give the picture, and this is probably, you know, nothing new to you, what happens when you don't manage this properly, besides all the operational hustles. But these are just 3 examples, and 2 of them are fairly new, the XVIVO and Hologic, both, I think XVIVO was August this year, and Hologic was end of last year. Philips, I think it's a little bit older. But it happens all the time.

And the costs associated are, huge. So… Shows the risk of full not anticipating consultation requirements in advance. Shows that guidances, while not low, are treated as mandatory in audits and recalls. I guess you're familiar with that, at least in the Europe, being union. When you get an audit, the notified body will certainly demand that you have your guidances listed in your applicable list of requirements. And for Philips. Shows that the cost of not capturing cross-domain requirements, material, chemicals, and biocompability, creates a big issue. It's not the full story. I mean, they did a lot of other things.

To end up in situations like these. But I think… And one of the reasons that they did end up here was that they didn't do the backbone Work properly first. So, why this keeps happening? The root causes and danger zones. Unjustified applicability, items included, excluded, without rational. not defensible. Guidance is submitted, auditors expect them, even if not law or legal documents, so it's missing entities in the trigger findings. you have… Static spreadsheets, so lack of version control, updates missed, rational lost. And… and one-off mindset, so it's… in many cases, I notice that it's treated as a document and not a living compliance process.

And then you have the market copy-paste. that you go for the EU MDR, and then reuse it for UK, Switzerland, and other national routes, and… Not being aware of the deviation, but there are. The entire Europe market is like a minefield of deviation, of… differently implemented, European Commission regulations. and directives that you have to be aware of. I know that in the US, it's probably a little bit different, because the fines are so low in states. This is very, very general. that it's actually… More cost-efficient to…

Take on the fines, rather than reaching compliance. Very general. Okay? So… Where we're at now, and… I have to apologize if this is starting to lean towards some sort of marketing session, but we're getting to it. My intention is not that at all. My intention is to, one, lift this question, because I think it's often overlooked. And we really want to find the best solution possible. And we really need your input in designing this. And we're gonna get there. But what we think is that what is required, really, is that you must go from the static lists.

And engage a living compliance method. So get rid of the Excel spreadsheets, and I haven't seen QMS systems that treats this Perfectly. In the way we think it should be dealt with. So what you want to have is that you need the cost level on the GSPRs. You need structure applicability with other regulations and standards and guidances. You need the justified rational. it has to be version controlled, sure, you can fix that in spreadsheets and QMSs as well. But it's cumbersome. Guidances must be included. And continuous updates, which… It's not a very easy thing to deal with when it comes to,

spreadsheets and QMSs, because you need to enter that manually, and you need to monitor all those sources manually. And it has to be aligned with notified bodies, position papers and… and guidances, again. So, what does this mean? Well. in my world, I think moving from those spreadsheets… you can… you can probably achieve a lot of those things in QMS and spreadsheets, and you get somewhere good. But it still comes with risk. So what we're aiming at is go from good to great, really. And, the difference… in what we think is good to great is that we can work with AI-suggested rational built-in

To challenge you? To guide you. When it comes to structure applicability, There's ways to… Generate automated cross-domain mapping. from… I'd say your company and product Attributes that could map that out. The justified rational, We could do a deviation summary and action plans versus markets, and harmonize. the bundle of, you know, main regulation from the European Commission, and all the variants that you find on the local markets in Europe, for example, or USA, with the local variants that you find in various states. Then version control, you could have practical audit trail prompts, and guidances included would be with relevant check against product attributes. Continuous updates.

That could be monitored and automated fairly easy, but also with AI-flagged implications. And I think the sum of everything. is the reason why this becomes so cumbersome. And it has to be… Designed in a specific tool that understands what the pain points are and treat them as we think they should be treated in the list upgrade here. And aligned with notified body, position papers, again, draft alerts when, when they, change. So… I understand that this might be a little bit visionary and blurry, and hard to get your arms around what we mean with all of this. So…

My question here is, who would like to reach great status in a few weeks from today? Because the reason why I ask is that we… since… This spring, I think April? Started to design a… A new version of Huden. Where you enter your product, attributes, company attributes. to identify the applicable regulations. And you can do that with Hooden today. But what we also did was that you… Can enter your… Sub… attributes. to identify what guidances applies and not. And this is also for cross-domain regulations and the related guidances.

And by so, figuring out what standards that applies. And, notified body position papers. And on top of that, get those… Challenging questions. and… and leading questions from pre-trained GPTs. I'm not saying they give the answers, that's not their job. Their job is to help you to get to the right answers and take the right decisions. So that's what we've been working with since the spring now. And before we launch it. Which we will, during this year. we, invite… Companies, which could be either

Manufacturers or consultants that help manufacturers To try out this in a pilot. So you could be the first to experience what we call the Next Generation Compliance Tool. And also receive those tailor-made, audit-supported lists… lists? Sorry. It's getting late in Sweden. You would get direct export, expert support. We have, for example, Martin King with us. But we only have 5 seats available. So, I just wanted to mention this opportunity because it's… new today. This is the first time we, we speak about Where we're heading.

And if you'd like to apply, just send me an email, or contact Sean, and he can pass it on to you. But… I think we have a lot to talk about. You might have a lot of questions, and I might have a few answers, so we have room for that now. And that was the entire presentation. We could jump in and take a look at what it looks like today, if you'd like. But I wanted to leave… The presentation stage here, and see what you are more interested in knowing, or challenging me in.

So, I'm gonna jump in. As you may know, I've worked for a number of SaaS providers, a number of information providers, and have been, you know, in this industry for more or less the last 25 years. And… Every, every time a provider comes along, they're like, we're gonna, we're gonna solve this, this great, big, hairy problem that all of you seem to have. And, There… there seems… to be… how do I put this? Okay, so this week, my company has been reviewing Monday.com, and Trello, and Asana, and Jira, and deciding which

you know, platform we're gonna use for… for being organized internally, right? And so, by analogy, my difficulty with those platforms is that they don't… think the way that I do. They're not actually… they're creating a workflow that is adding to my burden, rather than subtracting from it, and they're doing it in such a way that is counterintuitive to the way that I think. So, I hate those platforms. the… specifically the task management platforms, which are supposed to keep me organized and on track, and show… what I'm wondering from the audience is…

To what extent can you help Marcus frame The problem on the ground. Because… I think… That a lot of times, there's a disconnect between Why companies are struggling. And what they're struggling with. to the solutions that are being provided for them. Now, I'm not trying to, say that Marcus did this right or wrong, or anything like that, but the brilliance of this group is that we have people who have been dealing with these problems for a very, very, very long time. And getting to the root of what's going wrong, and why companies continue to get in trouble, companies as big as Philips, is just shocking. But yet at the same time, you know.

And so, yeah. That's how I would frame this conversation to be the most useful to everyone on the call. No.

Thank you, Sean. Yeah, you said exactly what… I thought I should have said. So thank you for filling in. Exactly! I mean, we're great at technology and software, and we know regulatory affairs and quality assurance fairly well, but we are not the people on the ground who has 20 to 30 years of experience. And… The… Those are the people that we would love to have on board for the next… 4 to 5 weeks. When we fine-tune the, the concept. Because we know what has to be sold. And just as those platforms that you mentioned, monday.com and Jira and so on, they also know what problem to solve. They have that in their technical documentation, and their user stories and requirement lists and so on.

But how to solve it, how to interpret that need and transform that into a software that people understands and likes and trusts. It's a different ballgame. And for that, to do that, as good as it… can be. That's when you really need All you guys. And that's why we call for it, because it's… it's crucial to us. So… If you have… the interest, if you have the need, if you have the experience. You don't even have to have the experience, you just have to have, the problem, really. But if you have the experience, that's even better, to solve this, to hop on, for a couple of weeks and, and be with us.

During the.

Just to put it up, let's… let's go to… Jermaine, is that… I… I… we haven't met. Hi, welcome.

Ask to unmute.

Hi, Sean. Welcome, everyone. Marcus and I have had a few chats, so Ian him are a bit familiar. I think, just to start off with a comment, other than getting to the questions. I think the good opportunity that, that Oden has, in my opinion, Is that, Normally, with most AI chatbots, your chat GPT, etc, as I highlighted earlier, are not exhaustive in the way they search for information. And that is typically because all of the most recent and relevant information is behind pay gates, so they cannot access that information for free. I think one thing that Houdin has in its… to its advantage is that Regulations are available for all.

So in terms of training the two on what is correct. That can be done almost perfectly, because every single regulation that needs to be followed within the pharma space, be it medical devices, orthodox medicine, wherever it is, every single device… every single regulation is published and is public knowledge. So I think from that perspective, you… we can safely assume that if the upload or the teaching of the bot is done correctly. Then all information that should… that it should have access to is readily available. So I think that is the… that is the advantage of a tool like this, because it doesn't depend on paid information.

And then to come to your question, Sean, of, the mandate.coms, etc, I think, most people are not looking for a program that thinks the way the designer made it. You want something that fits into your workflow, or your style of thinking, and still yields the result. So I think from that perspective, with hooding, you want something that can sort of do the reading for you, like, summarize the regulations, filter out what is needed, then deliver that for you on a plate, if I can say, then instead of you having to go through 15, 20, 30 different regulations, and singling out the sections, you can then have a tool that does that for you. Then from there, you now

Sort of apply your professional judgment and expertise to get to the final result. So I guess my question in that regard would be, Is Wooden capable of doing that at the moment? And is there a plan to do that? And then how, then, do we verify that, this search is exhaustive. So, for example, if I punch in a prompt. A guarantee of sorts that, this has indeed gone through, reviewed every available, legislation, piece of legislation that is available for that particular topic, that'll be number one. And the number two will be on the maintenance of the database. Obviously, I mean, especially in MedTech, I mean, we have

regulations popping up literally every day. So that maintenance also has to be up-to-date to enable a tool to to stay ahead of time, or to stay as effective as… as it sounds. I think that's, that's it for me.

Great, thank you. Yeah, just as Germain mentioned in the beginning, we kind of know each other a little bit from before. It's a rather new friendship. Jeremine is a brilliant regulatory affairs professional from South Africa, and, Thank you for the questions. Let me address the, The accuracy of content and data first, because that's super important. So… Let's have a look at a smart list of hooding, what it looks like. So, in this case. I have 25 bundles covering 80 major region regulations and law directives. I cover the entire Europe, and for North America, I cover some states, and of course, federal regulations, and Canada.

that means that I have… a huge amount of documents that has to be correct and updated. So if we look at Europe here, we have centralized procedure regulation, or we can take… We can take the… oh, sorry, my lights went out. We can take something else. Yeah, let's take orphan. So… First of all, This one has to be… we have to know that this is the recent version. We have to check the updates, this one didn't have any. And so on. So what's happening behind the sceneries here, knowing that all of these are related, knowing that there are, in this case, California is fully aligned, Florida, Texas, Utah, and Washington, but in Canada, there are some nuances.

The way we do this, without revealing too much. Is that we have spiders out on each… first of all, we verify that these are trusted sources. From the legal bodies. So there's a lot of work on the ground to identify everything and put that in our database. Then we have spiders out there looking every day whether something has changed. And when they recognize that something has changed, we get notified. So, I'm gonna show you something that… Pretty few people has ever seen. This is our admin. And if we go to regulations… We have all of them listed in here for a management view.

So let's go to Wii, for example. Then we check this, and I can run an AI validation on whatever findings our spider has done. And if it notices that there… and what the AI does in this sense is that it's reading the documents, the current… the first version we had, and the current version. Has anything changed? And if so, where? In this case, it didn't… it didn't find anything. I think my network is a little bit slow. So, no issues indicated, so it read both of them, and I will solve this, and then we see that it's last verified today. So that's the engine behind to make sure that everything is correct. Because if it's not, we might start to push incorrect recommendations and implications of updates and so on.

I'm gonna jump back to where we were at. So that's the one thing. And then, I think what you said, Jermain, regarding how to use GPTs and so on, is that you can't use a general GPT. Doesn't matter if you use OpenAI, or Gemini, or Copilot, or Claude. It has to be pre-trained GPTs. So we have hundreds of GPTs, and there have fenced-in tasks, they are only allowed to talk about roach, or they're only about to reason and read documents related to biocompatibility regulation, or a certain part of FDA regulations, and so on. They're fenced in. They're strictly prohibited to

to analyze or interpret anything else. And we have hundreds of them related to each document, and that's our… The main design of the entire system to make sure that it never gets General or, you know, outline of what it's intended to do. I think that answered both of your questions, I hope. Brilliant questions, by the way.

Can we move to Leo?

Once I get my malic.

if I look weird and, like, a dog looking up, so it depends, my other screen is a little bit higher up, so I look a little bit weird than the camera. Sorry for that.

No worries. So, first question, which I wrote in the chat was, are you using IMDRF as well for the essential principles and 40, 7, I think it is, and 52 for the labeling. Because that's similar to GSPR.

Yeah, exactly. So, when it comes to the GSPR, the current version of HoodN, what we see now, it's pretty straightforward. It's like a smart library that bundles things together, and that you can get. On alignment, and how everything fits together, which is how we wanted to design the backbone. When it comes to GSPR and other similar requirements, when you have to go down on clause and section level, and Provide rationals. whether it's applicable or non-applicable or into, conditional, that's… exactly where we're aiming when… when we talk about this pilot. That's next.

So we're… yes.

Okay.

I think… Yeah, I think they'll be very powerful, because then you'll be able to use a lot of… go around the world a lot more, because most countries are going that way, is towards the IMDRF.

Yeah.

Well, maybe…

May I ask, Leonard, do you have a Swedish background?

No. Not at all.

Your family name is a common Swedish family name.

No, it's, German.

Oh, yeah, yeah, yeah, okay, maybe that's…

Westphalia, part of Westphalia of Germany.

Yeah, there's a famous, very wealthy family in Sweden with Einstein.

Oh, I had no idea. So… Related to that. the withdrawn 16-142 ISO standard is sort of the basis for the IMDRF list. which was, essential principles of Safety and Performance of Metal Devices. Those got withdrawn about… I think it was about a year and a half, two years ago. I'm actually on the ISO TC210 committee that works on that, and TC, 20417 and 15223 with the symbols and the information supplied by the manufacturer. And I'm involved in 601, the medical electrical equipment. So, one thing I was going to ask is also, do you do surveillance on standards that are being developed?

Because that's one thing we help our clients with, knowing before they come on the market. Being ready for what's coming up is really important for design and development, so they're ready for the changes.

Yeah, that's a really, really good question, and these are the… these are probably the parts that I love the most. You know, being able to… to deliver a solution that looks into the future and prepare Companies and regulatory affairs professionals for Doing things right already early on. So, Yes, that's the intention, both when it comes to communicated and decided upon updates of standards, guidances, and, as well, regulations. We are there to… To, to, to tell that. and help them with interpretation. So, this is just an example that I'm sharing right now. So we have the SOHO regulation from the European Commission.

Which will, which is in force, but the start of applicability would be August 7th, 2027, so it's in transition. And the two regulations that it's replacing would be tissues and cells directive and directive of blood. So, a lot of things happening here. Two are collapsed into one, and it's going from a direction into a regulation, which means that the legal, effect is way higher for the member states. And here's what we're working on here, so you get a compliance migration Checklist, or migration notes. That, in this case, it's fixed, so it doesn't take into consideration what type of device that you're selling.

But what's coming in the next is that you will have the opportunity to use your product-specific information, to get more, you know, tailored… Advisory, regarding, any, you know, change, because something that will happen in the future is a change. And you'd like to have… A dialogue around that. Sorry for a very long and blurry question. I hope I got that right.

Okay, Lisa's had her hand up for a while. Lisa, we only.

Hi! Yeah, no, it's not going to take me very long, because I think I understand it now. I kind of wasn't getting the point at first, but I think I do. I kind of thought it was more like a… a tool for your, say, technical file or your QMS, but it sounds more like it's a regulatory intelligence tool That you will now be able to kind of tailor it towards your specific devices. So, look, that's… I really wasn't understanding what… I couldn't tell what it was yet. But it… since you showed us the, the demonstrations, it's… it's a lot… it's a lot clearer. Yeah, the, the slides were…

I was kind of coming at it from the other direction, as in, was this going to be some way of kind of producing the… your… your lists or something, and I really was like, okay, that… that… as… as Shauna kind of said, I wasn't sure if that was necessarily just another… Maybe another tool that… that… that you were… we were making a job for, but… Yeah, look, this is, I can see the utility of this if someone's not already using something. Similar, yeah. Yeah, thank you, and it…

It struck me while I was presenting that I should have… probably presented the tool as it is today first, and then talk about the journey that we're, heading towards, but I… I'm always… A little bit, defensive on being on webinars and just promote and try to sell a platform, because that wasn't really the intention. The intention of this webinar was to talk about The problem with having up-to-date, justified. lists of, of, requirements, and also invite whomever that feels like, yeah, this would be an excellent thing to join. To take it to, to the solution that is highly needed on the market.

And… and speaking of… thank you, Lisa. Speaking of how… how we… kind of map things out, is that we… Using AI, to give suggestions regarding the specific device and companies. So we collect a lot of metadata, rather than… having users submit their technical file, because I think they would be a little bit… Defensive on doing that. So, we read everything that is available regarding the product. Immediately. And then the user has always the final call to decide what should go in into the setting. And the user always have the final call on what should be in the list. And the user always have the final call read regarding status and rational and so on. We just try to make the job way more simpler to connect all the dots.

Between a product and a company, and the regulations and the guidances and the standards that are related. And if you think about that. thread of relations, selling a product on multiple markets, highly technical, advanced product. It's a giant Red. And it changes. So when you're done, Today, it looks different tomorrow. And that's really annoying. But that's the reality, and that's what we're trying to solve.

Well, thank you very much for, sharing this with all of us this week. I learned a lot. Your product has continued to evolve and change, in interesting ways, and I always get a lot from from you. I'm gonna just put, one more time. in the chat that I want everybody to complete the AI user survey, and to share it, because we need 40 more responses, so I haven't checked recently, but please take 3 minutes share this information with me, share it with your colleagues, it will make for a better report and a better course, to come out of it after the fact. We will share the survey results with anybody who takes the survey, anonymous, of course, and

Yeah, I, Thank Marcus, thank all of you for your time, as always. I hope you got a lot out of this. If not, you know, feel free to beat me up, privately, and, I, will, share the information, with Marcus, one way or the other. If you would like to be involved in the pilot, reach out to me or him, and, you can find him on LinkedIn very easily, Marcus M. Nate, I think he might be the only one. And Yeah, I'm one of 6,000 Sean Smiths on LinkedIn, so a little harder to find. I thank you again. If you have questions, comments.

And, we, are looking for a couple speakers in October, so if you would like to be one of them, and you haven't spoken recently, then, reach out to me, and, and we can try to figure something out. Thank you so much, everyone.

Thank you. Thank you very much.

Hi, everyone! Bye!

Funny.

Bye. Have a good weekend.

Great weekend.

Thanks, everyone. Bye.