MDSAP Navigating Multi-Regulatory Harmonization Webinar

Sure. Hello, everyone! My name is Lawrence. I'm a senior consultant with Acro team. and I generally focus on quality and regulatory issues for a lot of our customers. You know, I really enjoy helping people clarify quality requirements, because I don't think they should be that scary.

Thank you. Thank you. Sean.

Yeah. My name is Shawn Gibbons. I work at Philips. I'm a regulatory affairs manager. Specifically, I focus in software as medical device Cloud based AI machine learning algorithms. And I was asked to give a quick statement that any comments made today are based on my own opinions and experience and do not reflect the position or views of Phillips and his entities.

Thank you for that. And Matteo.

Hello, everybody! My name is Matteo d'angelo and project handler, lead auditor and technical documentation assessor at authorized for the main relevant schemes regarding medical devices clearly including on this app my main area of work is related to non-active medical devices in particular orthopedics. I started to work into suit in 2022. But before that I worked for several years at a large Italian company that relies implantable device on surgical instruments for orthopedics. I'm very excited to participate at this webinar. Thank you for the opportunity.

Thank you for joining us, Lawrence, do you want to go ahead and get started.

Absolutely. Thank you very much, Sean. So welcome again to the webinar on Mdsap. The medical device, Single audit program. navigating multi-regulatory harmonization while avoiding the most common compliance, pitfalls that cost companies, market access. What you will see and hear today includes information from published documents, as well as the opinions and interpretations of myself and the 2 guest speakers. So please take note of this disclaimer, and we've already introduced our guest speakers today, tail and sean. for today's agenda. We will discuss the background and history of Mdsap. Give you a sense of the structure and scope of the program.

We will talk about the key, defining features like the structure and grading scheme. and how it differs from other audits. And then we will have a panel discussion with our 2 guest speakers. We'll talk about common pitfalls. Let's get some insight from the industry from both the perspective of a manufacturer and auditor. and after that we will have time for some questions from the audience. So let's start with a little background to give you some context. If you are not familiar with Mdsa. What is the medical device single audit program. The original intention was to create a single audit that, if conducted, could satisfy the needs of more than one regulatory jurisdiction.

In other words, instead of having separate audits for every single region, what if there was a way to somehow combine them? So the clue is in the title Mdsap. Mental device, Single Audit program, one audit to rule them all. And they were not trying to make the regulations the same. That would be incredibly challenging. Instead, what they focused on creating was a unified, auditing method that would at least reduce the number of different audits needed. and therefore save time for both those performing the audits and those being audited. So it was very much driven by a desire to create an efficient, an effective program.

Now, who is this day I keep referring to. So it started with the Ghtf global Harmonization Task Force. which eventually dissolved. But the work was continued in 2,011 or 2,012 by a working group under the Imdrf International Medical Device Regulatory Forum. which I believe, involved at the time the 5 countries that eventually joined Anisa as well as China, Europe, Japan, and Russia. And so they formed this sort of international consortium Mdsap. And they have a regulatory Authority Council rac in the diagram on screen which consists of the regulatory authorities from the 5 countries that signed on Australia, Brazil.

Canada, Japan, and the Us. These are the 5 countries in which the regulatory authorities accept this single audit approach. The Mdsap. Consortium also has official observers from the EU Singapore United Kingdom and the World Health Organization. and they also have affiliate members from 7 other countries across several continents. Now, these observers and affiliate members, they participate to varying degrees. They're on the periphery. They cannot make decisions about the program, but they can participate in working groups. They can witness assessments and participate in forums. In fact, they just recently had a forum in Amsterdam, where many stakeholders gathered, and they talked about how the program is working potential changes in the future. And so on.

My interpretation is that you know they're at least curious about the success of the program, and may one day consider it. Now when they launched a program in 2,014. The you said they would make a decision about, you know, full participation a couple of years, and I remember when I was getting trained on Mdsap. In 2017. My trainer said that they wouldn't join any sooner than 2020 at the earliest. but soon after, as you all know, the EU regulations were being introduced Mdr. And Ibdr. And they clearly went in a completely different direction. But at the recent Forum there was some discussion about the potential benefits of them joining in the future.

Now, just as a side note, there is a tiny way in which an Mdsap audit report could be of use in the EU regulatory context, but it is certainly not as significant as the worth of an Mdsap audit report in the 5 jurisdictions. So what are the requirements in scope? While we have the international standard for Qms. For the medical device industry Iso 1345. And for the participating countries. We have these main sources of requirements. The regulatory requirements in each jurisdiction during the implementation of Mdsap. Is013-45-2016, had just come out

replacing the 2,003 version. And I think this happened sometime during the Mdsat pilot. Now it's 2025. So the 2016 version has been in place for a long time, and manufacturers are well acquainted with it, but you know this will need to be revisited whenever the next version of Iso, 1345 comes out just a couple of weeks ago the planned 5 Year Review was closed, so in a few months they may announce the outcome of the review at the bottom of the slide. It also says, specific requirements for the authorities participate in the program. So basically, you know there are some other requirements. For example,

21 cfr. Part 807, which is about established. Registration device listing. or 21 Cfr. Part 803 about medical device reporting. These are additional requirements that are not in 21 cfr. Part 8, 20. But nevertheless they are still applicable. Let's talk about the stakeholders. So we have the regulatory authorities from each participating jurisdiction. and they are responsible to assess. And if the criteria are satisfied, it will recognize auditing organizations. and they will continue to monitor their performance through witness audits and documentation reviews.

Then, from the device manufacturer's perspective, they would apply to an auditing organization to participate in Mdsat. This is how they would get an audit performed and based on this. The auditing organizations may communicate with regulatory authorities, you know. They'll let them know that. Hey? This manufacturer is going to undergo audit. And this is how the regulatory authority knows that they do not need to proceed with their usual audits. This is how one of the ways that Mdsap allows device manufacturers to save time after conducting audits. And you know, working with manufacturers to resolve any nonconformities. The auditing organizations will share results with the regulatory authorities, along with a recommendation for certification

or not. and then based on this. The regulatory authorities can use this information as part of their own process to grant a marketing authorization in their jurisdiction. Now this last point is important because the audit performed as part of Mdsap does not replace whatever market authorization activities are applicable in each of the 5 jurisdictions. right? The current product approval. Pathways are still relevant, and this app only replaces the routine auditing aspect. And I should also mention that Mdsap does not let manufacturers get out of open issues.

If you have nonconformities from a previous regulatory audit and one of those 5 jurisdictions, and they've not been resolved, they must still be closed out with that jurisdiction. So applying for Mdsap is not a sort of get out of jail free card, where you can forget the results of previous, and then move on to a new audit program. There is this nds audit cycle, which goes over a 3 year long period. So at the start would be the initial certification Audit. This would be followed by a surveillance audit in each of the following 2 years

and a recertification audit in the year after that. so the result of each audit could be initial certification, continuing certification or recertification depending on where you are. In this cycle, in the initial certification audit there are 2 stages. Stage one is a documentation review. It's to determine if the necessary Qms. Documentation has been prepared, and if the organization is in general prepared to proceed with the process. and also lets the auditors get ready for the onsite audit. That will happen in Stage 2 and let them know what to focus on

so they can save a lot of time during the site visit. So the stage 2 audit is the thorough evaluation of all applicable requirements. From what I said before, Isa. 38, 45, and the relevant regulatory requirements. and takes place at all sites that will be recorded on the certificate for surveillance audits, they check for the continuing compliance and effectiveness of the Qms. And each surveillance audit does not necessarily need to cover all the requirements that you covered in the initial certification audit. they will typically focus on changes to the organization like newer update products.

technical documentation related to their products or changes to your Qms. Processes. Surveillance audits also focus a lot on issues related to safety and and effectiveness that emerged since the previous audit. So we're talking about things like complaints, vigilance reports. any sort of field corrections or recalls. keep in mind that terminologies and reporting timelines do vary between jurisdictions for surveillance audits. There's typically no stage one, although there could be if there were huge changes such as I don't know. Major changes to regulatory requirements, for example.

And finally, we have the Recertification audit which goes through all the areas of the Qms. There are more details about this. but this is a, I think, a general overview of the audit cycle. and outside of the cycle there are also audits like special audits. so these could be conducted to fill in gaps between surveillance audits. Maybe there was some product safety issue that emerged. The regulatory authority wanted the auditing organization to investigate, you know, for example. or maybe there were major nonconformities that needed to be followed up on site. Or maybe there was an issue with one of the audits, and they needed to redo a portion of the audit because they couldn't complete all the tasks in the time available.

Maybe an auditor got sick or something. or there was some other obstacle on site. And another thing. There are also unannounced audits which are, when regulatory authorities need auditing organizations to follow up on previous significant nonconformities and alternatively regulatory authorities can do it themselves. They could conduct their own audits for cause. They have a specific reason. Maybe they want to follow up on something or just double check, that everything has been implemented. Let's talk about the audit process itself.

Perhaps the most important document that manufacturers would need to reference is the Mdsap audit Approach document. I have the document Id there on the screen, and we'll provide links after this. This document includes specific instructions about how the auditing organizations perform the audits in this program. When Mdsap launched there used to be 2 separate documents, one called the Mdsap Audit model, another was the Mdsap companion document. In case you come across these documents or these names just know that they have now been combined into one figure one from this document is what you see on the screen here.

So the mbsap audit approach follows this process-based approach where they've grouped audit tasks into 4 primary processes, management measurement, analysis and improvement, design and development production and service provision. Then there is the supporting process of purchasing. as well as 2 additional supporting processes. device, marketing, authorization and facility, registration and medical device, adverse events and advisory notices reporting and the arrows in this diagram represent links between all of these sections. This is because there are a lot of links between these areas in a Qms.

it's a fundamental aspect that a lot of requirements are intertwined and related. So when you think about one area, you may end up interacting with another part of the Qms. Purchasing, for example, is a supporting process that has important links to measurement. design, development and production and service. So you might confirm that a purchasing requirement has been implemented when auditing another section. the Mdsap audit approach document explicitly mentions these links to help you navigate them at the top of the diagram. You see, risk management, and it surrounds the other main processes. This is to emphasize the fundamental nature of risk management.

and how it is considered throughout the audit. If you have excluded design, development from your scope, or deemed certain requirements not applicable due to the nature of the device or how the organization operates that is carried over, and the auditing organization would not audit those requirements as they remain outside your scope. although it is presented as a sequence. They won't always be able to strictly follow this order, especially if you have multiple auditors auditing in parallel. But this is the general sequence of activities. And it's a helpful way to look at the processes and how they're related.

We don't have time to look at the audit audit tasks in detail today. But I would encourage you to look at the Mdsep audit approach document if you haven't already. and it clearly shows each requirement from Iso. 13, 4, 8, 5, and the associated regulatory requirements from each jurisdiction. Another one of the defining features of Mdsap is the grading scheme. This is an excerpt from another of the Nbsf. Documents au p. 0, 0, 3, 7 dot 0 0 2. There are 4 criteria, and for each one the auditor applies a score based on the outcome. So, for example, number one, is there an indirect or direct impact on medical device, safety and performance. So here we're saying, if if the issue is with something like manager responsibility or commitment.

the quality policy, responsibilities, management review. these have indirect impact on the device, whereas if the issue is in something like product realization. anything from design to post-market that would have a direct impact. So if it was a direct impact, for example, you would give it a score of 3, and the second one is, is it a repeat issue? Has it occurred in audits from the last 3 years? Yes. at a score of one. Was there no document procedure, or was a required activity? Was there a required activity that was not performed? If yes, give it a score of one. and finally did actually lead to the release of any nonconforming device.

Now, if you do the math quickly, you realize that you can end up with a maximum score of 6. But as a rule they've kept the score at 5. And again, there are more details about this grading scheme in the document. Id. That's listed on the screen there. So in summary, some of the benefits of Mdsap include the fact that there's no additional requirements for manufacturers. You still only need to consider the current requirements for the countries as well as Iso, 13.5. It is a single audit which theoretically lets you use less time and resources to prepare for and undergo audits. And there's a routine audit cycle.

So that everything's scheduled in advance. And there's that predictability of the structure, the sequence of activities. How long you spend on each activity. And finally, there is a chance that more regions will join the program at the beginning. There was also excitement about at launch, about an increase in a number of participating regulatory authorities, and I think that's probably something that a lot of manufacturers would look forward to as well. So that is a quick overview of Mdsap. In the amount of time we have. We will include some links here some resources that might be helpful. You can access them after the webinar.

And now I think we will jump to a short audience. Poll Sean, do you have that ready.

You should be seeing it now, hopefully.

So you guys can just go ahead and complete the poll. And while we wait for the audience, let's bring in our guest speakers. So once again we have Mateo d'angelo project handler and lead auditor from Tusud and Sean Gibbons. Regulatory affairs, manager from Phillips. So why don't we start with you, Mateo. in your experience with an auditing organization. I don't know. Do you have a preferred Nbc. Chapter, that you'd like to audit the most.

Oh, well, definitely the manufacturing process. Because I enjoy seeing and getting hands on with how how devices are actually made. Observing the production step, the different applications and our company structure they controls, including process validations. Of course, this is my just my personal opinion, and not specifically related to and the sub. For me it applied to any scheme clearly, but it is anyway clear that with Md. Sub. Very structured approach, the production session become even more exciting because you enter the production area already aware of what most relevant to look at because you have performed before. A lot of you have already inspected the management process, the measurement analysis process, and therefore you have to collect a lot of information to know what you have to see in production.

Yes, absolutely. Yeah. It is always one of the most exciting parts of the audits when you get to check out the manufacturing space. And I know you. You often see people like, do you ever wonder if they've like cleaned up the area a lot more just because you're arriving.

Yeah.

Yeah, is. It is definitely one of the most exciting parts. how about Sean? From your perspective? Do you have a least favorite Mdsap chapter. Maybe something you don't like preparing for.

Fair question. I I will say it's a bit of a cop out answer for regulatory. But definitely the adverse event reporting falls in that least favorite bucket. Any company doesn't want to be in that position. So when you actually have to use those procedures, it's never fun day. And then for auditing purposes. I find that a lot of companies have a lot of questions around the different requirements for each jurisdiction. How? What do you consider your become aware? Date? What do we do with new information? How are we reporting everything and making sure that information flows correctly to all the right regulators in a timely fashion, is definitely a struggle that many companies face and

because it's not a favorite part of any organization. Sometimes they just don't always put the best resources towards there. And yeah, not not the most favorite part of that audit.

Yeah, no, that's totally fair. That is definitely understandable. Sean, how are we doing on the poll? Do we have?

We're we're gonna go ahead and end the poll. Share the results really quickly. There we go, so and back to you.

Perfect. Thank you. Alright. Well, let's turn to our panel. And why don't we start with the theme which we had in our subtitle there about compliance, pitfalls, and audit findings? So this question is for both panelists, what are the 3 most frequent Mdsep audit nonconformities that result in market access delays and what root causes typically drive these failures. Why don't we start with you, Mateo?

Oh, well, 1st of all, it is. It is important to underline again that Md. Sub does not introduce any new requirement, and it is based on 1345 requirements, plus the applicable regulatory requirement of the Md. Sub jurisdictions. This means that it is not entirely accurate to associate findings directly with Mdsap program. But rather we can talk about findings that emerge, thanks to the Mdsap. Approach the approach encourages the auditors to create many connection between the different audited processes and push sampling based on risk, complaints, incidents, nonconformities, or Kappa.

There is, therefore, a strong emphasis on the procedures that guide these processes, and it is not uncommon to issue findings on Nonconformity and capital management, as well as risk management processes additionally and linking to your 1st question all processes verified at the beginning of the audit of the of the audit sequence, allow for very direct and specific sampling in production, often revealing findings related to inadequate quality controls or ineffective process. Validations. then typical root causes include the insufficient trainings, lack of resources or typically non robust procedures.

That's right. Yeah, that's really unfortunate. But they don't have the procedures at all. In the 1st place, seems very unprepared. Right? Yeah. And what about you, Sean? What sort of frequent nonconformities do you see from your perspective.

Yeah, I think my perspective lines up a little bit with Matteo's there. Kappa management is definitely one of the top of the list. Any manufacturer who goes through Kappa's or anyone who has ever worked on Kappa's knows there's there's a lot of question when you do root cause analysis. How deep. Do you go? And then also making sure you do a left right look to all of your procedures. So really encouraging manufacture manufacturing companies to make sure when they do. Kapla's that they're looking deep. They're asking all the right questions. They're not just coming up with the simplest answer and implementing the 1st thought that comes to their mind

so capital definitely a big one design control deficiencies. So when they do their Bnb planning, do they make sure that they link it to the risk management procedures and the risk management file, do they again, double check is what they're implementing and what they test in their Vnb actually covering what their missed risk mitigation is calling for so following up on all of that testing, and, like, I said before, at 1st event, reporting, making sure that you understand each one of the jurisdictions, what their timelines are, and what the expectation is for your reporting for post market events.

These are 3 that I I think any manufacturer can struggle with a little bit.

Yeah, absolutely. Yeah. Those definitely sound very familiar to me as well. This next question is from Matteo, how do companies most commonly misunderstand Mdsep requirements? Do they have a misconception about the program? Is there some documentation that they could have easily prepared to avoid nonconformity?

Well, a frequent, a frequent mistake is assuming that meeting the Iso. 1345 standard is enough to ensure complex across all jurisdictions. Well, while Iso, 1345 is a great starting point. It does not cover the full picture. Each country has its own set of specific requirements that need to be addressed. and these requirements are essential to successfully navigate through the Mdsa audit. There are several examples we can made, for example, different countries impose strict timelines for reporting product incidents or adverse events clearly missing these deadlines can lead to regulatory issue and even delay in market access.

Different jurisdictions, introduce specific requirements for labeling Ifu content, often including language requirements. Other. A lot of jurisdiction require companies to partner with a local agent like FDA, for example, who act as the official interface between the company, the manufacturer, and the regulatory requirements. and and this agent perform activity that varies significantly from one country to another. and then another example could be the risk. Classification of the products is not the same in each. Jurisdiction is like different country by country, and each risk. Classification may lead to a different conformity assessment, or to a different regulatory pathway.

So all these aspects, if not properly addressed, can lead to findings by the auditing organization, and also significant delays in the specific regulatory pathways managed directly by the authorizer themselves. So to ensure smooth market entry and avoid costly complex issue. It is, in my opinion, crucial to understand the specific regulatory requirements of each market and tailor. The strategy, accordingly. getting these details right from the start, will help the organization to navigate global regulations with confidence and avoid unnecessary delays.

That's perfect. Thank you. This next question is for both of you. If you could change one thing about Mdsat to decrease the compliance gaps. What would it be? Would you change the sequence of auditing how long you spend on a certain task? The grading scheme? Let's start with you, Sean.

Yeah, I think anyone working in the software as medical device space, especially cloud based? We, we find that because we're kind of on that cutting edge. A lot of these auditing schemes were made for more classical medical devices. So one thing I would love to see Mdsep incorporate is a little bit of tailoring of their auditing practices. So depending on the device type, especially when I'm talking about software as medical device, really making sure that they're creating some flexibility and tailoring of that audit specific to that device versus just going through chapter by chapter. Kind of having that rigid scheme that may not always apply to your device, and then you have to discuss with your auditor what applies what doesn't apply? Which can create a little bit of delay in the audit as you have those discussions.

Yeah, I I think for me that would be the biggest thing.

That makes sense. Yeah, how about you, Mateo? If you could change one thing.

In my view, any gap that may be the default are not a result of the Md. Sub itself. So and this app is another program. It is not a standard regulation, so the applicable requirements remain remain. Those defined in Iso, along with the requirements. What truly needed to happen, in my opinion, is a greater harmonization of these regulatory requirements. That would make things easier, not only for manufacturers, but also for auditing organization. While Mds up doesn't change the audit framework. One of its foundational objectives has always been harmonization.

and the focusing on that on that goal could help reduce confidence gaps moving forward. It is, in my opinion, something that it was in the the previous, in the, in the targeted initial targets of the the program. and then we have lost along the way, because now then, this problem is focus on on the orders. on the audit structure, on the audit approach, on the fact that you can skip, or you can merge 5 audits in one. But one of the targets was demonization.

Yeah, no, that's a very good point. I was always sort of pleased with how well they they lined up all the requirements between jurisdictions together in the in the document. But you're absolutely right that there's definitely a lot of work that goes into making that happen. Let's talk about strategic benefits. Let's go with Sean. How much do companies save in terms of time and stress with this model. where you have one audit instead of separate audits? The requirements are the same. But is there a lot less headache because you have fewer audits to go through.

Right. I know Lot, no matter how many times you do an audit. There's always plenty of stress, plenty of planning around it, a lot of preparation. So for me and regulatory. And I know my quality team. Really appreciates that one complete audit versus trying to schedule the entire year out trying to figure out budgets for travel, trying to figure out what rooms we're gonna be booking where the auditors are, gonna be who our auditors are is also a big thing, since you build a personal relationship with your auditor over time. So in terms of stress, definitely huge benefits to your regulatory quality and your other departments within the entire company.

And then for just planning purposes, getting it all out of the way at one time. you can build your procedures around this audit. You can centralize your procedures so that way, you have less sops floating around to make sure you keep updated so that way. Great centralization of those and also another benefit to the overall organization is response times after the audit. If I have FDA coming in a response to a significant finding is very short, very stressful, and versus Mdsep, which buys you a little bit more time to work with your auditors to get the correct responses out and make sure that things can continue operating as normally

final point time. Also, whenever an audit comes around in my perspective, company has to shut down. Basically, you're preparing for this audit. You're getting everyone in the right room setting up your front back room. That's a lot of time lost that could be spent on better activities like getting market access. Making sure all your procedures are effective. So definitely a lot of stress and time savings.

Absolutely. And and you have, you know, theoretically fewer different findings. Right.

The exact.

So you can kind of like collect your time instead of having to track 5 different findings for maybe the same issue. You just have the one.

Exactly. Yes.

Systems. There, let's talk about the implementation and transformation. If someone was to adopt in these app mateo from. I'm sorry. Actually, let's take a different perspective. First, st Mateo, from your perspective of an auditing organization. When Nvsap came in, how was the response from your perspective? Were there challenges with training recruiting auditors to perform audits that sort of thing.

Honestly speaking, I I don't know, because I wasn't working for an auditing organization at the time the M. The sub was introduced. However, I can imagine that the existing auditors were used providing them with a solid training plan. So integration of the the auditor schemes. But what I can say is that when I was authorized for this scheme I had a very pretty, intense training, but the real value came from hands on experience in the field, because the structure of of approach is very particular, and it's very stressful for the auditor as well.

And I guess that back in 2016, when Health Canada made the Md. Sub certificate mandatory for accessing the Canadian market with a two-year transition period. A lot of companies, I imagine, rushed to get certified all at once. which probably push the auditing organization to quickly ramp up trainings and authorizations.

What about now? Do do you find other challenges with? You know, having the right auditors with the right skill sets to perform audits? Or is it a pretty stable environment.

Oh, it's it's a typical audit where you need to be well prepared when you arrive to the company. So you need to study the company they processes their documentation received in in advance in order to start to understand what you can sample during the inspection and the sequence of the task you would like to follow. And therefore it is very important that the auditors, as a very good organization, a very good plan, so precision organization are typical skills of the auditors, but they are in this case,

very important.

Right? Absolutely. Sean, from your perspective, how do companies deal with the resource allocation for nbsap. you know, if if they save time and resources? Is it a challenge to justify their quality and regulatory personnel.

So I, yeah, I think that's gonna be the 1st thought of any company is now we're coming down to a single audit. Great do we need all of these resources which to me, that's really a short sighted plan. You do free your resources up to do the jobs that they're hired to do. Quality can now focus on cost saving whether it's scrap reduction, making sure the plans for Bnv are thorough, so you don't have recalls in the future. and then now regulatory, can focus more of their time on market access, even outside of Mdsap countries. this allows me to now look forward and plan for additional market access, instead of thinking who is my next audit coming up? What do I have to prepare for our procedures, ready for the different reviewers that come in.

So for justification of those resources, I think companies really have to be forward looking and looking to grow and not just cutting the bottom line.

Yeah, I think a lot of times. People don't seem to realize all the other duties that quality and regulatory personnel have. It's not just defending audits.

Right.

What about I don't know. Organizational changes or cultural shifts. Do you think there's anything like that that's necessary to navigate Mdsap implementation.

From a cultural perspective. I think that companies across the board every department need to sign up to own their own procedures and take participation in these audits. A a quick downfall for a lot of companies is, they just say, Okay, regulatory quality. Your audit people. You handle this whole thing. We'll see you in a few days. So definitely a cultural shift there and then, also making sure that the company is living in their quality system, making sure that they're reviewing their pro procedures. They're reviewing the reports that coming out of it and doing their management reviews to see, is it actually effective for what we're doing now. This is something that even if you're outside of Mdsap you should be doing. But now you have more of a focal point. You have

your planned one year review that everyone needs to come together and make sure that they're ready for. So I think that helps with that cultural shift as well, since pre planned and everyone is prepared for. What do we need to do to be successful?

Let's switch gears and talk about future proofing and emerging technologies. This question is for both of you, what is one question you would like to have answered by the Regulatory Authority Council that is in charge of Mdsa. Is there something you want to know about future expansion plans or changes to the program. Anything like that? Why don't we start with you, Mateo?

For me. The big question is definitely whether there will be an expansion to other countries. if and the sub were to expand in into Europe, for example, being both an Mdr. Notified body and an organization could really benefit from that and offer a full service solution that said, it all depends on how much value the European Commission would actually place on the Md. Sub certificate within its own conformity assessment process. And this rationale is valid also for the other countries.

Right. What about you, Sean?

Definitely also with the Mdsap expansion anytime that we can harmonize, and for myself, as regulatory, make my submissions more streamlined and easier. Any company is going to be looking for that help. As I mentioned before, any auditing practices specific to software as medical device changes cloud base and adopting AI practices that each one of the Regulators is starting to move towards and plans for that in the future is definitely information that would be valuable to manufacturers.

Sean. How should companies prepare their Mdsap compliance frameworks for upcoming requirements related to artificial intelligence or machine learning, device, oversight and algorithm validation, expectations.

Yeah, so.

This is always a fun one. Especially when you get introduced to the AI machine learning world. Definitely, algorithm versioning is something that companies need to make sure they take seriously. When we're talking about software as medical device, it's very simple to make changes for engineers go in. It's not like your typical hardware. So things can move fast. So making sure you have that versioning in place. So you have an audit trail to know how your devices changed over time!

Strong validation plans. There's a lot of black box mentality around AI. So making sure that your validation is very robust, so you can cover all the use cases that maybe you possibly didn't even think of because of the nature of AI, and then a real world performance monitoring we always know that we try to be as robust as possible with the validation, but when it's put into real world use there could be changes to how the device is performing. So making sure you're monitoring that very closely. and then following the typical 6, 2, 3, 0 4 framework that sets a good boundary for software development, and it should be taken to heart by any manufacturer. Because I think that's really how you build a successful Qms around software development.

Another aspect that I think is always overlooked is data management practices. You're seeing a lot of regulators coming out with requirements. For how do you collect your data. How do you store it? How do you clean it? All of those should be well defined and simple to access for any auditor. If you want to have a successful implementation.

John Smith, how are we doing on time?

We have 10 min left. 9, really? And so we have a number of questions in the Q&A. 13, to be exact and that's more than we can possibly answer. In the next 9 min.

Sure. Well, why why don't we jump into the Q. And a. Now then.

Gladly. so let me just jump in with this question. Does Mdsap auditing organization, communicate certificate suspension, and withdraw directly to regulatory authorities? Are we clear what that means?

I didn't catch that sorry.

Okay, does Mdsap, auditing organization, communicate certificate suspension and withdraw directly to regulatory authorities? I'm not sure that the auditor spends.

Kind of.

Okay.

I think I can hazard with this question. what the auditing organization do is to recommend or not the the issue or the continuation of the Md. Sub certificate. Then it's up to the regulatory authorities. Define what happened for this manufacturer on the market. So the auditing organization closed the activity when forward the information to the jurisdictions.

Okay, thank you. So sort of is is a Nonconformity. Is is it a Nonconformity? If the company wants to participate in the Mdsap program, but does not have specialists for each jurisdiction.

Does not have specialists.

I believe you'll run into issues when it comes to the establishment registration certification in specific regions. top of mind, Japan. You may have to have a local authorized rep to cover your licensing. So if you're not specifically going for that jurisdiction, it may not be an issue from Dsap. You would just leave that out of the scope of your certification. But I would definitely look at the local market, understand the regulations before you go into Mdsep. So you can decide whether or not this is going to be needed for your company.

Fantastic. And this is a related question. Is it possible to take part in the Mdsap program? If the company only covers, eg. Canada and us? FDA.

Yeah, absolutely. They. They just need to decide which jurisdictions they want. And those would be the ones that are in scope.

Exactly so. Once audited for all Mtsap regions can a manufacturer sell into that region? Assuming no licenses are required, IE. Class one devices and required registrations. Listing or notifications are done.

I think the key. There would be the required registrations, listings, notifications, and also making sure that your sales procedures, your post marketing requirements, all follow local regulations. You should be able to start sales. But again, I would make sure you work with the local rep and make and understand the local requirements before you start shipments, because there are local requirements that are not covered under Emd, set for each one of the markets.

Good. I understand. Next question, if our company is based in the U.S.A. Is already FDA registered, and Iso 1345, certified. Would that reduce the audit required to achieve Mdsap certification for Canada. So 13, 4, 85, certified in the Us. FDA registered. Would it make it easier to enter Canada.

With Mds. At the end of the day. You you need the Md. Certificate to access Canadian market in any case. for sure, if they? If they have Iso and FDA registration, it's probably easier for them.

Hmm.

But in any case you need to have them. The sub certificate for Canada. And another additional information important is that if you apply for a country like Canada for Mds up, and you sell your devices also in other 1, 2, or all the other countries, and the sub. You have to apply to all of them. You cannot select just one if you sell also in the other.

And Mateo, I I think, what they might be looking for is there is no is there an abbreviated audit process which I not working for notified body. I I don't believe there would be an abbreviated process. It would just be. You're already more confident that you have the evidence for the Mdsap certification having your Iso. 1345 certificate already. but myself as a manufacturing person. I'm not aware of a abbreviated audit process.

Nor am I to both of you. What advice would you give to a manufacturing organizations or tools would you recommend, without naming any proprietary tools as an effective means to maintain compliance to regulatory requirements, to different, to the different jurisdictions.

So regulatory Intelligence Platform is gonna be one of your best friends. You're working across multiple markets that put out multiple requirements all the time, and you have to find a way to meet these requirements. And then also, how do they bridge to the other jurisdictions you're in? so definitely need to make sure your regulatory intelligence is up to date, and then your filing structure as well. I know a lot of companies move towards the Eqms. So just making sure that your files are organized, readily accessible. And that there's clear connections between your sops and your reports and all of your product related documentation. You don't want to be caught digging through everything and finding out that you're missing a document because you didn't create a good traceability or organizational

structure for your Qms.

Very good.

Just to add to that, I mean to. Both of Sean's points are super valid. Yeah, it's not just to change your regulations, but there's guidance documents all the time. There are white papers. You can find that help. You kind of walk through. What are the changes and how it impacts you as a manufacturer. So I do recommend people to look up different regulatory intelligence platforms, or set up your own kind of crawlers that can collect information and feed it into your inbox whenever things come out. And for the Eqms side, absolutely, it's how often do people struggle to find the right record during an audit, and it's such a struggle. It slows things down. The auditor starts getting anxious because he can't get information and move on.

Yeah, definitely looking into the right Qms. Platform to store all your documents, records. And there's a whole industry out there that works on that kind of thing so definitely. That's something they should look into.

And I'm sure Lawrence would be happy to follow up with any of you that would like more specific information on how acroteam can help you establish that we have about a minute left last question. Countries who accept Mdsap certificate example, Singapore, South Korea? Do they need a specific Mdsap country in scope, or would any do or any would do. I think I understand the question.

From my knowledge, I do not believe they specifically look for any country included. They just look for your certificate, because then they're gonna incorporate it into their own ums audits.

Fantastic. Well, I'd like to take a moment to thank our speakers, Mateo Sean Lawrence. Excellent job today, very informative. Again. I'd like to remind everybody of the quality accelerator program in Munich, September 3rd and 4.th If you'd like information on that, just write agenda in the chat, and I'll send the agenda over to you. And lastly, I'd like to thank everybody on behalf of Medtech leading Voice and Accra team for joining us today. We value your time, and we look forward to your feedback in the survey. Thank you.

Thank you very much. Everyone.

Thank you.

Thank you. Bye, bye.

I.