Global Regulatory Submissions Made Simple

Hey everybody, and welcome to Friday in Focus. I'm Sean Smith from MedTech Leading Voice, and I am very happy to have the team from Pure Global here today, Julia, Michael, and Oliver, and We are going to get started in just a moment. I want to give you a quick preview, a very quick preview of what's coming up. Next week, Leon Dorn, is going to be talking about his experience with AIML FDA submissions, and some of the hard lessons that he's learned along the way. That's going to be a really valuable session, and I strongly encourage you To join. We have a webinar coming up on the 30th with,

LeanRIQA and, Fernanda Nussbaum from TTI Health. It's a… it's a reboot of one they did in November, backed by popular demand. We've reframed it a little bit, and changed the focus to, really understand why MedTech launched this stall. And then, we have the Utimed is coming, It's like, what do we say? there's… yeah, we all know that's coming. And This is… this is new, first in human clinical trials, with, Julio Martinez-Clark,

And then we're gonna have, the QMS conversation your clients are having without you with Charles Rolay, from TraceX. So those are the upcoming events. Then, I want to remind you to register for the International MedTech Safety Conference. If you're in or near Boston, please consider attending. You can save $250 with or $200 with our, MLV discount code, virtual or in person, so even if you just want to go virtually, and virtually is a lot cheaper than going in person. Now, it's not as much fun because there are no cocktails. But, you can have your cocktails at home while you watch it. So, there's that. And then, big news, Vetronic is now… that's Sonotron is now in the final four of, voting.

And so I'm gonna paste that, manufacturingcounts.org slash vote in there. If you're a pet lover, you know, please vote for Andre's device as the coolest thing developed in New Jersey, and 2026. And then, the last thing, I just want to let you know that LeanRIQA has a new Substack, called Medical Device Regulatory Briefing. And I want to put in a plug for Substack. Substack, look for a lot more people publishing on Substack in our industry. It's a really good platform. You can monetize it, or you can do it for free, and if you create a free publication on Substack, it's free for you, which is great.

I think that is it, so I'm gonna stop sharing. And I am going to turn it over to Julia and the team at Pure Global, and shut my mouth. If you have any questions, please put them in the chat or in the Q&A, either one. We'll be looking at it. And as always, I encourage comments from the Peanut Gallery. So, without further ado… Let's get started.

Over? Oh.

Go ahead, Michael. I just wanted to… but go ahead.

Oliver, you're on mute.

Now it's working. Sorry, I was on mute. Yeah, so my name is Oliver Eichenberg, so I'm the Global QA and RA Manager at Pure Global. Actually, I have a serious experience or background in the medical device field, so I started a long, long time ago. Just when the, in Europe, CCEMark, was actually new, and I've experienced over this time 15 years in the industry and 15 years in the, in the consultancy space. So, and have, seen a lot of these, medical device companies, and a lot of changes over time. Yeah. So… With this, I'm giving it to Julian.

Hi everyone, I am Julia Wareschi. I have 5 years or so experience now in the medical device industry. I'm originally from Italy, as my name can show, but I've been living now in the Netherlands for the last 6 years or so, so I partially see now the Netherlands as my new home. And on the topic of Netherlands, Michael Floortez. also the Netherlands with me.

Yeah, thank you, Julia. So, my name is Michael Vanderwood. I've been in the medical device, global market access, international business development space for more than 20 years now. Lived in the U.S. for many years. And, back, back in the Netherlands since… since about 5 years. You know, a little bit about… my personal interest and experience in this field. You know, I know from experience that, you know, expanding into global markets can be complicated and costly. I've done that many times. Also worked with many companies who have been, gone through this process. And our focus… My focus, our focus, has always been, we want to make the required regulatory part of having to go into, going into global markets.

as easy and affordable as possible. So, so that all companies, not just the bigger companies with, with deep pockets, but all companies, smaller and mid-sized companies, can bring innovative technologies into markets, markets all over the world. And hopefully. You know, during this session, we'll be able to talk a little bit more about this, and how we Try to, to make that happen. So, thank you. Thank you, everyone, for attending. So I'm going to do a… just a one-slide introduction on Pure Global, which is the organization represented by the three of us. You know, we provide, medical device market access to more than 30 markets worldwide.

We're a young company. We've been in existence now for 5 years. First two years, a lot of the focus was more on FDA, was more on clinical, and we really kind of switched focus to global market access in the last three years, with a new approach in mind, as I mentioned, as I mentioned earlier. So, we're a young company, but we have a lot of experience within the business, all over the world. We have teams all over the world. The blue… the blue markets are the markets where we can support medical device companies. The red dots actually represent our own offices. So we have put a lot of effort into opening up offices

And, bringing in local regulatory staff to, to support, to support our customers. And 13, and this is really key to the, you know, to the solutions that we offer to our customers, is that 13 of the red dots are actually representation entities. So these are markets where we, through one of our own pure global offices, supported by our own staff. can offer representation and registration support. And that allows us to offer this in a more innovative way, since we are building this in-house and not relying on partners in these markets to make this, to make this happen.

So that's a very short introduction. We want to make this an interactive session. I think Sean already mentioned that as well, right? So please feel free, we don't have an official presentation. We have a few slides we're going to go through. We hope that the slides will trigger some, you know, some comments, questions. So feel free to, you know, to interrupt. To, you know, or to write something in chat if you, want us to focus on something specific, or if you want to share one of your own experiences of the things we're going to be talking about. But I'm going to hand over to Julia for now.

Yes, thank you, Michael. So, global market access. Here we can see a general landscape of gold market access potential countries for entering your medical devices. Of course, we can start off with the United States. This remains the largest single market globally, right, that we are aware of for medical device placement. Similarly, of course, we have Europe, right, in the European Economic Area, which covers together around 30 countries. Then there is Asia, where we see there are several high-growth markets, such as Japan and China. There are major contributors with strong regime frameworks and increasing demand. South Korea and Singapore also stand out as efficient,

Yeah, and expedited reviews pathways, right, from the authorities, the local authorities there, making them very attractive markets, actually, in the Asia region. Emerging markets, like Vietnam, for example, or Indonesia, also are, although they're smaller today, they are still growing rapidly, so it's also important to keep them in mind, as well, as potential markets to expand. in the region. Well, then we can go to Latin America. For example, if you look at Brazil and Mexico, they are known as the leading markets in that area of the world. Brazil especially offering strong potential, because of the alignment with the FDA pathway. Mexico also now, recently, since September or so, becoming more accessible due to the new abbreviated pathway.

write an approval routes, so we're not limiting anymore to FDA, but actually now is accepting also CE, which, of course, improves the speed to market. And then going back to the center right here, we can go to the Middle East. Countries like the UAE and Saudi are also investing heavily in healthcare recently, creating new opportunities. for manufacturers to enter these countries. Even their CE is currently seen as a primary pathway across, those countries as well, in general, most markets. Where these authorities, local authorities, are really relying on CE and supporting, CE as the evidence for local registrations.

And then, of course, we can go to markets like Australia and UK, which also remain important, because they're very much stable, they're known regulatory systems, and again, here you can leverage CE marking to enter both. So really, if we look at this map, the key takeaway, considering the countries just mentioned, right, is that combining CE and FDA approval can unlock access to more than 25 or so markets. Globally, often this means, faster timelines, right, in comparison to pursuing each market individually, or independently, rather. So, you know, this helps out strategically, because then companies

Can ensure… manufacturers can ensure that they can align their regulatory approach across With these two pathways, in all the different countries, or markets, rather, that they want to enter. And so here, I give the floor to Oliver to actually go into the specifics about how you can use FDA and CE approval to go into your specific countries.

Thanks, Julia. Yeah, so on the next slide here, you can see, yeah, we broke it down to, okay, how can you use FDA going global? So, as Julia mentioned, so… the CE or the FDA could be a significant strategic, financial, and business advantage for you to streamline this expansion into new markets. But what are these markets? Here, actually, we separated this into leverage levels, so FDA accepted. for example, for Israel and Japan, are quite new in Japan, and also FDA supportive, which means it is recognized by FDA, or FDA is recognized, and allows a bridge pathway, or reduces, definitely significantly, the time to market.

And here you can see. There are a number of countries, maybe the list is not yet complete, but we selected Saudi Arabia, Brazil, Mexico, Singapore, Malaysia, Thailand, India, Australia, Canada, Taiwan, Hong Kong, South Korea. So there are a lot of opportunities here, just with the FDA, to grow global. And… If you look at the next, slide, it's even more for CE, so when you have the CE, in some countries, you have a direct recognition. In other countries, the leverage level is more that is accepted, like the UK, but still, you need to, of course, comply with the country regulations, and then it is supportive, which means that you, again, have the local approval required.

And you can see that there are a significant number of countries where you can use your existing CE to go global. There are, of course, a few, whatever limitation. It might depend also on the class of device. You might have a specific… A specific… limitation for legacy devices, so this could happen, but overall, this just shows you, okay, there are a lot of opportunities from, when you have CE marking, and it is worth then to consider Okay, what opportunities do I have, to go global into these markets?

Yeah, and… okay, so… How do you do the medical device registration submission? And we have here, on the left side, the traditional, and I will take the traditional, because as I mentioned earlier, so I'm in this space since 30 years. I have seen all these ways, how is it done in the past, so you… the traditional way is, okay, you're doing your manual research. Even in the earlier years, it was not… there was no, whatever, internet or database, you have to go to the library and search. Nowadays, you have all this, but, you still need to search across the country-specific regulation. This… Takes a lot of time,

then you have the medical device dossier, or the technical documentation, assembly and review. So… also for this, you will go through, or the traditional way is to go through this, to do a gap analysis, a completeness check. Manually, then you… to assemble the technical documentation, review it again, update documents, be consistent, make sure that everything is complete. avoid redundancies in multiple documents. So, this is the traditional way of doing this. And then finally, also doing the registration submission, which could be also a very time-consuming and administrative work, from the RIA peer persons or QA persons. So, overall.

It is… What has been used from many, many people who are still working in the QARA field, but we all know it's a lot of administrative work, and it is less efficient. And it, of course, it is associated with resources and higher costs. So, let's look on the other side what AI can do, and how I can support this today.

Yeah, on the other hand, indeed, AI actually, when it comes down to regulatory updates, can help you already scan. Right? The country databases and regulation and authority websites without you going one by one manually. So that in itself already saves a lot of time for us as RIA experts to see which information, which update is actually really relevant. Instead, we have the AI, Supporting the scanning, and what we do is then check one by one which we want to bring forward, right, and to help our clients. Overall, then one can assume that around half the time. Already is saved because of the initial scanning.

Of course, it could be even more, depending on the updates actually occurring. However, I think the biggest support from AI, in my opinion at least, comes when it… to the medical device dossier assembly and review, and then the submission to each authority of the market selected, right? You can have AI help you create initial completeness check to see, really, what documents were provided and what could be missing. For example, if that's a DOC or a GSBR. Also, that means it can lead to reviewing an initial gap analysis, right, and making sure that documents provided by the manufacturer are structured in the order that you need for the submission. That, arguably, is a lot of admin work, right? That already the AI can save you time and help you.

Of course, this does not mean that the specialist is not there anymore. The RA specialist then is involved because they conduct the detailed review, right, of the documents provided based on the initial assessment done by AI. If you think about it, that initial assessment can already minimize review time by around 40 or 50%, depending, of course, on the quality of the documentation provided. But the manufacturing question. At the same time, if you already have AI helping you do the initial completeness check, that review can then be leveraged for other markets. So, for example, if we're starting off with Mexico, I can already use this review for Mexico, but then I can already leverage it for maybe Colombia.

Right? I don't have to do double the work anymore. Instead, I focus on the specific national requirements or components, right, that I need for the specific submission of that country. And that, of course, then leads to, yeah, overall the registration submission time and the preparation of it already cuts so much by having AI do the admin work. And in the end, it also saves time for the manufacturer, because we can work then in parallel, thanks to these tools that support us in our reviews. So that's why we conclude that, in the end, having AI-supported tools when it comes down to registration submissions become more time and cost-effective overall per market registration.

Yeah, there's a question from, Danielle.

I'm sorry.

Oh, can you hear me?

Yeah, I can hear you. Okay, possibly.

There's a question in the chat. if we have data on how much time is saved when you go from traditional to AI-supported. I mean, you're making a generic.

Yes.

Right? But we have been working with it for a while, right?

Correct. We have. We actually, as Pure Global, have a few builders that we've been using. Brazil being the first one we actually started working on, and the Brazil team at Pure Global actually ended up telling us that when they use the builder to support them, around 50-60% of the time for them is actually saved. Thanks! to AI, because there's a lot of admin work originally, right? And now we're seeing that the same is applicable for countries as well, like Mexico. which is another strong builder that we started using in Thailand as well. So we are trying, as Pure Global, we started off with one country, and that same concept, we're expanding it to different countries because we see how efficient it is, the system.

So, I hope this answers your question, but I would say, in the case of Brazil, we're talking about 50-60%.

Thank you.

Michael, floor to you.

Yeah, my favorite topic. So, along with a different way of being able to, you know, to collect the document, the required documentation, compile the… and compile and translate the dossier, you know, and all the time savings associated with it because of, because of using AI in-house developed AI tools. We… we also… you can also expect, and you should also expect, a different type of pricing structure. Right? So, again, of course, the traditional way, Oliver earlier said, you know, how many years he was… he's been in the regulatory field, and he knows how registrations have been… have been billed the traditional way. The same can be said, you know, from my experience, right? 20-plus years.

You charge an annual fee to act as the representative. You charge a consulting fee to do the technical file, tossier compilation. You charge for translations. You, once the device has been registered, if anything needs to be changed, if you need to change something at a model. If you want to… in some markets, if you want to add a distributor. Any other changes, administrative or technical changes, then, trigger another consulting fee. If the regulatory authorities contact the representative and they have questions about the product because they received some feedback out of the field.

from a hospital, from a doctor, from a patient, and they want… they're doing… they're doing an inquiry, hourly, consulting rates go, you know, are being charged. And all of this is… you know, is under… is… is already put together… is already agreed to in a contract, and you can't… you cannot do anything against it, right? So it's lawyer… it's lawyer-like… Billing. And because you're dealing with a representative, the representative is, you know, is in control, and you don't have a choice but to pay, right? So, That… that is what we want to change, and because of the… the efficiencies that we gain with compiling the doss, translating dosets, and the 50-60%

efficiency gain. We applied… the same can be applied to modifications. And because we have, you know, we have our own offices with our own teams in place, we feel that, you know, if there's an AI-supported approach, there should also be AI-supported pricing. And that… and that we should expect to happen more, I think, in the industry, is that the annual fee becomes an all-inclusive fee. So, it does not… it does not, matter what activities are happening in the market, you're paying an annual fee. All the activities I mentioned earlier are included in the annual fee, and there are no surprises.

And no additional consulting fees being charged. And that has… and that is directly linked to being able to… to have a more efficient approach to… to getting the, to getting the submissions done. In these, in these local markets. Think only about translations. Translations used to be such a high… cost element of entering a new market, and now you have all the AI translation tools out there that make it so easy to… to do translations. And there's… there's no need anymore to… to charge for all these activities piecemeal, because we know that there are efficient ways to, to put together the,

put together the submissions and any other post-market type activities. So you're going from unpredictable costs, right, that can be charged at any point throughout the contract to more of a subscription-type type contract. When you sign for a 3-year contract, you pay an annual fee, and… It's all… everything that needs to be done to get and to keep the product on market is included in the annual fee. Go to the next slide, Julie.

There's a question in the chat box, from Pete. He asks, how do you provide evidence that the translations are validated?

No. Good, good question, and we, we get that, we get that question, more, more often. You know, we're, we're including the translations that, that are, required, during the submission process. Right? So, and the regulatory consultant, the local regulatory consultant or expert, would typically do this, him or herself, in the past, and it is now done with the support of AI. If, certified translations are, are required, or validated translations, then that's a, that's a separate, that's a separate step we would have to, we would have to look at. So, what… and then… and Julia will show a little bit later how, you know, how this works in practice.

By, taking away… basically, we're taking away the translation burden and activity away from the local consultant. and having AI prepare it, and then it gets reviewed by the local consultant before it gets used for the submission.

Yeah, maybe, maybe just to add, I guess we also need to separate translations, which are used, for the, for the submission. Where it is, of course, then accepted to have, whatever AI tool or so. But, and the translations, which are specifically focused on the labeling, which is put then on the market, and then, are used for the device itself, for the user, which is then used and written by the user. So this, of course, is then under the final responsibility of the manufacturer. sure, and must be, in the end. controlled by the manufacturer and released by the manufacturer. And of course, this process might be supported by AI, but there must be an expert at the end looking at this, or a specific whatever service provider who has the qualification for this, and then releasing this. So I guess there are two elements discussing these questions of translations, but for the submission itself.

these kind of burden and these kind of translations. These, in my understanding, do not need to be, whatever, validated or so, and automatically, quite often, even the systems do checks, at least for consistency, and then also for completeness.

Yup. Thanks, Oliver. And this is an example, and this is an example of how the annual fee can work. This is on our website. But we have published our pricing on our website, so we have a fee calculator, and basically you select the markets you're interested in, and you indicate how many listings, the risk level of the product. And it will calculate the annual fee that is paid, and it will also provide the government fees that are charged in that market for these products. So it's a… it's a very transparent, predictable cost structure, which, which we feel is, is, is the future.

Thank you, Michael. So I think here we can start showing a little bit, actually, the document builder that I was mentioning earlier about how AI can actually support us, in the registration submissions to the local authorities. So here you have a few screenshots that show actually how Pure Global's builder works. And again, I also want to emphasize that this is an internal tool that Pure Global is using, and their specialists are using. It's not currently Being sold anywhere, so it's just for us to use to support our work as representatives in the countries in question. So, first of all, what happens is that we upload all documentation provided by the manufacturer in the tool, and let the tool start a completeness check to see what potential documents are missing, if that is maybe a risk management report or a CER. So then we get an input from

The builder on what documentation potentially is missing for… to conduct in the gap analysis. Then, at the same time, the builder starts extracting all the information from the provided documents based on the registration requirements. So, they are already within the builder information that we know is required to be filled out in the administrative forms to the authorities. So the information then gets pre-filled, translated into the languages in question. And again, here, the translation is specific from an admin perspective for the forms. So we're not talking about labeling, we're not talking about IFU.

We're specifically talking about administrative forms that need to submit it… to be submitted, sorry, to the authorities to conduct the national registration, right, on behalf of the manufacturer as their representative or registration holder, depending on the country in question. the form gets… the information, apologies, gets pre-filled, translated, and then structured, and then the RA specialist, the local specialist, starts reviewing the information provided by the bot, including the builder, sorry, including the translation of the builder and what they did. So they can easily… the specialist can easily edit that information in case it's incorrect.

Right, so it's not that the builder gives you something and you have to go with it, no. It gives the ability to… as a starting point, and then the specialist can add to it if it notices that information is missing, or the information extracted may be incorrect.

I've got a question.

Yes, Michelle.

Is the, translation certified? Right, because that's a big thing that the notified bodies are looking for, is the certification of the translation house.

Which is why, as I mentioned, it's not about labeling an IFU. Most of the time, notified bodies check the translation that is certified your rights in relation to labeling an IFU. We are not conducting that, Michelle, right? Our focus is specific to the documents, or the forms, rather, I should say. for the authorities. So here, actually, in the screen, you can see it on visa form. This form is for Brazil, right? The form is filled… it needs to be filled in in Portuguese. So to help our local specialists, right, who are Portuguese natives, but to help them out fill it out, they can already have the AI builder fill that information for them in Portuguese, and then they can check it in case it's incorrect, for example.

Or say maybe the builder made a mistake and put something in English, right? Then the specialist can go check it and say, oh, actually, this needs to be in Portuguese, let me translate it. But at least it saves them time instead of filling out each component one by one themselves. So that's the idea, right, of the translation section of the tool.

Thank you.

Yeah, no problem. So, continuing, here you can see another few screenshots of how the builder, the document builder works. So, the information, of course, again, gets reviewed and placed in the applicable administrative templates, or forms, rather, in the structure that needs to be submitted to the local authority. The builder, as mentioned earlier, pre-fills the selected templates. Updates the structure as need be, translates the documentation related, again, to the form, the admin forms, into the local language, and makes it ready for submission. Then the specialist can download this pre-filled information and start reviewing, right, the final content, right, for the pre-submission, and the translation as well.

Finally, when everything has been reviewed by the RA specialist, and they deem it it's ready to go, of course, they, as specialists, submit the final documentation to the Compton Authority, either in the portal. Or physically, such as in the case of Mexico, unfortunately, you know, there it takes more time, because the specialists need to print everything out, make an appointment with the coffee priests, and physically go there and submit your registration.

Yes, thanks, Julian. And I want to add is… what's very interesting is when you look at time saving, you know, part of it is, of course, not having to fill out this form by hand, right? It gets filled out. through the AI builder, and then, as Julia said, already in Portuguese. So it gets… it takes the required information from the documents that have been provided that needs to be filled in the form, needs to be provided in the form, but it's all information that already exists in the documentation. So… so the AI builder finds it. pre-fills it, and then in translated form, so instead of the consultants having to do this by hand themselves. But what they also mentioned is that, for example, the gap analysis, you can imagine that if there's a lot of documentation.

it does take a long time to, you know, obviously either a human or the AI builder to do the analysis. And what they're… what they mentioned is that, you know, they could… they could run… they could run the, the, the builder go to lunch, come back, and, you know, it's complete. Or if it's even a much bigger file, they may just start it before they leave at the end of the day, and the next morning, they come back in. It's there. It's done. And while it's running, if they're doing it during, you know, while they're still present, they can still… they can do other things. So it's not just… the, you know, the administrative pieces being, the time savings is not just in the administrative pieces being handled by the ABO, but it's also… you can do… you can multitask a lot… a lot easier, and so that all adds up to more efficiency, also just

On a… in a day's work.

Yeah, that's correct.

And I guess there was one question about the completeness and consistency, and I just want to comment on this, that this is, of course, this is included in the builder, so you… because AI will select one information, it would also notice them if this is maybe different in other spaces, or even it would fill in only this one information, and then in the applicable fields, and make it consistent. Maybe more consistent than a human could do. But in the end, you can see it, and you can double-check, of course, this information. And this is always where the experts have a close look at.

Yeah, and there was another question asking if the builder pulls the information from all the documentation uploaded. Yes, it does, unless the specialist unselects some documentation. So that is also in the power of the specialist to see, to us, the document builder, from where to pull the information. Usually, it is from all documents, but if they want something specific, then they can select specific documents and pull the information from there. Yep.

So, I guess usually the experience is that we select specific documents which are required for a specific builder, or for a specific form, and we then automatically pre-select this so that this information is, or can be just searched out of these documents. So, for example, 15 to 20 key documents. They are uploaded, and then the form can be filled out automatically.

Yup. And then back to… you know, what Oliver presented earlier about accessing markets with, you know, and basically using, leveraging CE, or FDA, is that… And then taking Brazil as an example, where a lot of the documentation that is needed for a Brazil, for an on-visa registration. already exists within the CE technical documentation file. So that's… that's why… so the… so we can ask a client to, if they already have CE marking, provide us your technical documentation file. And then, we'll, we'll do the rest.

Yeah. And then once it's in the builder, if we're doing it for Brazil, then we can use the same documentation for other countries as well, because it just works the same way, right? So it makes it also more efficient for us to then submit it to the new countries that the manufacturer wants to add in the scope.

Nope.

But then again, we always have challenges, right? So here, I think, is what we want to ask you as an audience. What are common challenges you're facing, currently, or have faced in the past, as maybe manufacturers trying to enter all these markets? We only listed out a few here in our slide, but we also want to hear your opinion and to see how, maybe, Pure Global in general We can help, right, and find a solution to these common challenges.

Yeah. Yeah, a big… a big question for me to take the first… first topic at the left, left top. You know, yes, when you go into these markets, most markets, you need… you need to have a local… a local representative, right? An authorized representative, or a license holder. A registrant, a sponsor, marketing authorization holder, whatever it's called, legal representative, all kinds of different terminology, but it all basically comes down to the same thing, is that you need to have someone in that market And in some cases, it's a person, but often it's also an entity who has to… Hold the registration in that market, or is… is the point person

For the local… for the local authorities to, with… if they have questions, because they want to be able to go somewhere local. We're all familiar with that principle. But I think we still see a lot of, a lot of companies, and I think from a cost perspective. And maybe from an ease perspective, selecting their distributor also to hold… to hold the registration. And that's not… that is not a… does not have to be a bad decision, but it needs to be strategically thought through, which is very important, because there are markets Where, you know, where the local registration holder has total control of the registration, and determines who imports products, determines who gets added as distributor.

And, you have to think about That if the commercial relationship with a distributor does not go well, which happens, right? It happens to all of us. The local partner may not fulfill its obligations, or you may come to a disagreement, that they always… that they then have to hold that as an ace card in their hand. Now, not all markets are the same. There are markets where it's very easy to change a representative. There are ways where it's very easy to re-register. Or maybe the market is not as important commercially. And then it doesn't have that much impact. But I think the only thing I think what we always emphasize is at least think about it strategically. Just like you would think about, as a business, do I set up a sales office?

Or do I work with a commercial distributor to distribute my products in that particular market? That could also differ from market to market, depending on the strategic importance of a market and your strategic goals. The same, you should do with deciding who holds the registration. We do the same thing. I mean, like I said, we support, we can support you, we can support manufacturers in more than 30 markets, but we decided to set up… to set up our own office in 15. And in the other markets, we decided to work with a partner, because we did not think… it was not as important for us to have our own office there. But in the key markets, where we believe it's most important to have a local presence, we set up our own office, and we have, we have our own, our own people.

So I don't know if… you know, that's… that's an area, I think, that is… that is very important from… in a very early decision to make when looking at a new market.

I'm curious to hear from the people in Europe on the call with regard to local distributors and authorized representatives. You know, I heard on a call, you know, Europe is not a unified market. From, from an investor's perspective. investor was saying, you know, the U.S. is a giant, unified market. True, you have all sorts of distribution challenges, sales challenges, market challenges, you know, getting on hospital systems and reimbursement plans. But, you know, you multiply that by 28 or 30 when you move into Europe. What is… what is your experience with that, you know? Obviously, registration is the first step in a… in… in entering these markets.

Anyone have any comment on that? Or not? Okay.

Maria E. Donawa, MD: Sean, let me… Try. I… Maria E. Donawa, MD: So, the whole point of the CE Mark is to Maria E. Donawa, MD: address all of the variety. I mean, talking about working in the area for a long time, when I arrived in Italy, there was… there were no directives, and every country was different. Maria E. Donawa, MD: So, I think the issue is that the variation is when you conduct a clinical study throughout Europe, you may have Maria E. Donawa, MD: differences in competent authority approaches. I don't think they're dramatic, but they can be different. Some countries can be more logical in their approach, and some countries can be more challenging.

Maria E. Donawa, MD: And then you have the language issue, but what you were saying Maria E. Donawa, MD: I mean, comparing the U.S, or I think that's what you were doing, or what they were doing, to the variation in Europe, yes, there are variations during the process of getting the CE mark, and of course, everybody knows that Maria E. Donawa, MD: there are variations in notified bodies and what they think, so that's where the variation is. Maria E. Donawa, MD: if you can get past that, and you have your CE mark, then, now that I'm… the more I'm saying, the more I'm agreeing that there's a problem here. But, of course, then you have local marketing issues that you have to deal with.

Maria E. Donawa, MD: As well, and also reimbursement issues, because in the U.S, there's an advantage of having basically one system, whereas in Europe, each reimbursement… each system in Europe, country in Europe, has different reimbursement. I think I've just made an argument, or made points that support the problem of variation in Europe, and my intention was to actually Maria E. Donawa, MD: talk about the benefits of the CEMark, so I didn't… Maria E. Donawa, MD: I did not meet my own objective.

I think you did both, you know, deep in the conversation, so I appreciate it.

Go ahead, Michael, fix it.

Maria E. Donawa, MD: Great, yes, great idea.

No, I mean, CE is a… is a… is kind of a starting point. Right? So I think, you know, yes, you need CE to be able to sell your products anywhere in the European Union. Which is a huge market, of course. A lot of people. That the markets differ, totally agree, right? I mean, obviously, it's completely different to sell your… try to sell your product in Germany than it is in France or Spain. I mean, that's, So commercially, yes, you need to look really from one market to the next, and have a strategy in place. How are you going to roll out throughout Europe? But CE does give you access.

Right? So CE is the first step, and you need one authorized representative for all of the European Union. and… but… but I agree with you that after obtaining CE, which gives you, you know, as an additional benefit, not only access to the EU, but also to a lot of these other markets around the world that are looking for CE-type documentation. But then, yeah, the commercial side is, is another matter. Totally, totally agree. Are you looking for Carrie, or are you looking for something else?

So, let's hear from our MD7.

I'm enthusiast.

Oh. And… and what… what MDSAP brings into the mix, versus ISO 13485.

Another mess. Just kidding.

Sorry, I'm a troublemaker today.

Yeah, so if we look at the, at the challenges from the QMS, so actually, I guess we have all seen a lot of harmonization and changes Over the last years, and we all know it has not stopped, so just look at the QMSR just coming into effect in February this year. You could see in China there are significant updates also to the Chinese GMP. aligned with these 13485, but adding also additional requirements. So, you can look at, worldwide, actually, it is still a continuing process that this is more harmonized, but it still keeps also the country legislation and a lot of historical aspects.

So that whenever you… move into a new country, or when you consider global market access, so the QMS requirements to consider and to update your QMS according to the applicable, maybe, legislation then is, of course, required. And I've seen this so many times. Even these small changes with CE, when people are moving to the, for example, just for Europe and just applying for UK, or for Switzerland, but, the QMS is not reflecting whatever the vigilance or PMS procedure, respecting these, UK or the, the Swiss, legislation. So…

Yeah, so… and everybody knows that the QMS is the umbrella for everything, actually, and is driving all these changes, and that this is required, but I guess there are still… we are still seeing a lot of challenges, or that these QMS are not updated, and of course. In the end, it could then end up in a delay to market. Right? Because you are missing something, you need to update this, nobody knows how to do this. Okay, we can support in all this, but, I guess also the databases and the way how this is… this registration is done in databases, how this is searched. this is also, or these searches are looking also at compliance, and this is also focusing on QMS. So…

a good sodium 485 or MVSAT is helpful for many, many markets, and it is… but it is also important, yeah, to comply with all these relations, and to consider this to avoid, then, delays in global marketplacements.

Can I just jump in here? Yeah. I think reimbursement is really important, because I've already gone through an exercise in the past with one company, and they got a CE mark, and they said, okay, we're going to market. And I said, well, what about reimbursement? And they said, what? Reimbursement? So they spent 2 years, which they didn't have market access, and I guess my question… to pure globalists. Do you cover reimbursement? And I just want to add one comment, a completely separate topic. I'm of the opinion that everything has to be validated that gets submitted to regulatory authorities, or will be reviewed by regulatory authorities. It has to be validated.

I'm using AI tools to do my grammar check, my translations and stuff, and I got a bunch of garbage out this week, so… I'm a true believer in validation, and it has to be correct. And you also have to consider the liability issues associated with poor translation. Thanks. And actually, my question was with reimbursement. Do you guys cover reimbursement as well? Because that is, for me, something that has to be considered at the same time as looking at the regulatory strategy for market access.

Yeah, no, and I totally agree with you that it's an element you need to, you need to consider very early on in the process. In some markets, we offer also support with reimbursement, but we're not reimbursement specialists. So we, and if we… and if a reimbursement specialist is needed, then we do have some, some people in our… in our network we can refer to. But there are some markets where, where the local representative, also is involved in reimbursement or in applying for tenders, for example, which we can then… which we can then do.

But, we're not reimbursement specialists.

Thank you.

And just for the, for the validation, so maybe just look at this example. So, in the past, or when we had, for example, compiled a 510K, So, you had to write these 21 sections. So you write it, you put in the information, and of course, if this information was not written in the original language. Then you have translated it. I have seen… No, actually, manufacturer providing here validated information for this. The content, what you include and what you simply submit. This is just in the submission. This needs to be clearly separated from everything what is placed on the market, or kept on a medical device file, yeah?

So this, and I'm not aware of any, legal requirement, actually, that this is… FDA do accept this, FDA has every and every regulatory authority. So this is simply where you can include the information, and this is, this is up to you, finally. For example, a general description of your device. Or a summary report. Okay, if you have a test report, if you have something, then the manufacturer usually translates it on their own, and then they put a stamp on it, or maybe confirm this. But usually, also, this is not… is not specifically… I've never seen FDA coming back and questioning this. So there's…

That's why, what… specifically also what Julia mentioned, there needs to be a separation, and this is what we clearly mentioned. In the information from the form, it's not what you submit on the labeling to the market, just for the submission process. And for the improvement of the device.

I have been involved in the validation of all the labeling and the regulatory documentation being submitted, and it's been more than one company in which it was a core piece in which the documentation that was being submitted, including the labeling, was validated. And, of course, with a poor translation. the user might use the device incorrectly, and then you go on to other problems, like liability. Who is then liable for the damage?

No, this is exactly what I said. When you place it to the market, the manufacturer is responsible. Everything what the manufacturer keeps as labeling and provided to the market, I totally agree, this must be… there's many regulations, there are specific requirements, also in, on the European MDR and IBDR Article 10, to have, of course, and controlled validations. That's clear. That's clear, for all the labeling and all what the manufacturers put on the market. That's clear. Yeah? For sources, I totally agree.

maybe to clarify, Stephanie, so in the case What we would do is we would ask the manufacturer to provide, for example, their IFU in Portuguese that they have certified and validated, and they're labeling also in Portuguese, for you, taking Brazil as an example. And that'll be submitted to the authorities, but that comes from the manufacturer, and that's the manufacturer's responsibility to ensure it is certified. And validate that translation. On the other hand, what we would then use the builder is more to fill out, for example, the NVISA form, right, and support that type of translation. Which is there, where the RA specialist, the local specialist, would then ensure that a Portuguese used in that form is indeed correct. And again, that has then nothing to do, because it's more administrative for the registration within Visa, versus, of course, the labeling, which would come through the manufacturer directly.

Andre, you had a question?

Oh, yes, sorry.

What the other question?

I think Andre had a question, but you're on mute.

Yeah, yes, I did.

Thank you.

Thanks to Sean and everybody for voting for our VetSonotron veterinary device, I appreciate it. But I was really interested in today's presentation because we are a medical device engineering and manufacturing company, FDA registered and ISO 1345 certified, and what we… besides our veterinary device, we do all contract development work for customers. And very typically now, we have, for example, one customer that's going through a 510K at the FDA, another one going through a PMA, and both of them, you know, they're smaller companies, they're a startup, more or less, and they've totally shied away from doing anything internationally.

because they feel it's just such a high mountain to climb, they just want to stick with the United States, especially with the concerns of MDR and all that. So I was certainly interested in Pure Global, and to see if that's something that, you know, they're looking for maybe, like, a turnkey situation where they can turn this over and really be guided in being able to bring it to other countries. So I know the time is short, but I'd certainly like to speak with you about that.

Yeah, that would be great, Andre, thank you. And, you know, what we do during the initial discussions with all our clients is we, you know, we can generate a classification, a grouping, a roadmap that is part of the sales process. So if they have… Certain countries in mind, or they want us to… to get involved in maybe identifying which markets maybe to focus on first, again, because they have FDA, not CE, timelines in the different markets, and then based on the classification and grouping, we can, we can do, we can do an initial, pathway Report, basically.

Sounds good.

Happy, happy to, yeah. And in general, I just wanted to make Sean ask me, okay, how do you guys work with, with, with consultants? I mean, we're… We recognize that we're really specialized in these global markets that many other companies do not cover. If you have clients, and you're working with them. or the U.S, or for CE, but they're also interested to go into Latin America, or Southeast Asia, or the Middle East, for example, we can support you, and we do have a, you know, I guess an affiliate program. Depending on how you want to be involved in the process. So, so as under… we can operate under your umbrella.

You can refer to us, you could take on part of the, of the initial process, right, if you would prefer, and use us as the local representative, for example. So all those options are, are on the table. We're very, they're very flexible. We like, we like to work with, you know, with peers, as, as, as much as possible. And see how we can support, your appliance.

So, go ahead and drop affiliate into the chat if you'd like to have a conversation with them about, you know, how you might work together. I think this is a strong opportunity, particularly for solo consultants. Who may have clients who are looking at going into other markets, and I would like to take a moment to thank today's speakers and panelists and audience members. For joining us today. We had well over 200 people on the call again. Spread the word, follow along, follow us on YouTube, and join us next week for… Ugh, AIML. Pitfalls. Thank you, pure Global, do you want to say goodbye to everybody?

Yes, thank you all very much. We appreciate the invite, Sean. Thank you, thank you. It's been a very great experience working with you, and feel free to reach out if you have any questions. Thank you.

Thank you all very much.

Thank you, have a great weekend.

Thank you, everyone.

Bye.

Have a great weekend. Bye-bye.

Bye.