QMSR Unpacked: The New FDA Playbook for Quality System Readiness

Go. Hello, and welcome, everybody, to QMSR Unpacked with Michelle Lott and Don Bales Metz. I hope I said that close to right. I'm excited about today's webinar. many of you don't know this, but for the past, I don't know, 4 or 5 months, Michelle and I have been working together on putting together a series of courses around, QMSR, and all of the different aspects of it. And it's coming together today in this powerhouse webinar, which is gonna give you the tour of the menu, so to speak, and a flavor of each section, and I'm really looking forward to this. Without further ado, I'm going to turn it over to our speakers.

Oh, housekeeping announcements, sorry. Housekeeping announcements are… this webinar will be recorded, slides will be available. To, everyone, and tomorrow. Let's see, and if you have questions, put them in the Q&A. And if you, have questions for me, put them in the chat. But if you want the speakers to see them, you have to put them in the Q&A. Second… secondarily, is… If you would like a certificate of attendance, please put your name and email addresses. You would like it to appear into the chat, and and we'll make sure that you get a certificate of attendance in a few days.

don't… don't pester me about them. The, and then, yeah, so… and there's gonna be a poll about halfway through, and there's gonna be a survey at the end. I really, really want you guys to do the poll and the survey, because, you know. I do. It helps us a lot, it helps us understand where you're coming from, and there's an echo. Somebody's saying, okay, well, that's probably, So, Michelle and Don, when I'm not speak… when I'm speaking, please keep your microphones on mute, and so if you're not speaking, just keep your microphone on mute. That should probably cure the echo problem. So, okay, so we're gonna get started, and I think that I'm done my announcements.

Oh yeah, and I'm speaking this Friday, on Friday in Focus, on the Silent MedTech Expert. I'll put that in the chat. Thanks! Looks good.

Until you're on mute.

Yep. Thank you, everybody, for your time, and joining us today, especially those of you who might have been following my messages on QMSR, my other presentations, and LinkedIn, and want to have a deeper dive on it with us. So, I'm Michelle. I am the principal and founder of LeanRA and QA. I've been in the industry for a little over 20 years. I've served as an industry representative on an FDA GMP Advisory Committee. And then I'm the Master Grief Counselor, because regulations sure do bring out all those emotions and people from anger to bargaining. And then once you're ready to get to the acceptance phase, we can get down, and get down to work.

And this is my colleague, Dawn. She has been with Lane REQA a little over a year now. She has been in the industry about 25 years, and Dawn, if you want to talk a little bit about your background?

Sure! Hi everyone, my name is Dawn Balash-Metz. I'm a U.S. citizen and a Swiss citizen. I live in Solator. That being said, I'm an RAQA consultant with over 25 years of experience in the medical device industry. I have deep expertise in U.S. FDA, EUMDR, and global regulatory frameworks, spanning device classes 2 and 3, hardware. Orthopedic implants and combination products. And, I'm that… with that, the global translator of regulatory gibberish, and I'm happy to speak to you about, EUMDR and its role, along with the ISO 1345 and QMSR, with colored commentary today.

So, again, for those of you who follow me, you know my executive team. They are taking naps right now, but if the murderer, serial killer, mailman comes by, I can make no promises. My background noise. So, we're gonna go through, a lot today. Not only am I gonna go through, you know, my experience with my clients, role, experiences with QMSR thus far in all of these very specific subsections. Dawn, as we go, like she said, is gonna provide a color commentary about how some of these things are looked at, you know, from an ISO and MVR perspective. And so, Sean, I don't know if this is a good time to…

Put up one of the poles, the first one. Nor if you want to wait a couple of more. Sections.

Let's… let's wait a little bit, because it's all three questions at once, so…

Okay, got it. I know where to stop for that, then. Okay. So, thus far, do you really feel like you know what it takes to be ready when the FDA shows up with their new inspection methodology? Oh, one other bit to Sean's point about the questions, please do put everything in the Q&A, because we have… this is an action-packed agenda today, and so if we don't get to your questions. We'll be sure to send out a separate document with the questions and answers, all in one place. So, what led me to the idea for these courses is that you can look back for years, and pretty consistently, you've got the same

topics that are the top drivers for 43 observations, out of FDA inspections. All of these, you know, were directly mapped to the QSR, and they… under the QMSR and ISO 1345, they are mapped to specific subsections of the ISO standard. And the reason that I started looking at these is because you know, these are areas where industry has always failed to meet expectations of the FDA under QSR, and so now adding on the additional requirements in ISO 1345, and the quality management system regulation, we can only expect that these are going to increase in scrutiny and number.

You're a squeaky. Oh, sorry.

Go ahead.

Here as well, to give an EU framing, notified bodies are typically asking the same questions, so you'll see the same, issues, but just with different auditors. Basically, notified bodies are asking, fundamentally, did you follow your procedures, and can you prove it? And FDA is now asking the exact same thing under the QMSI.

Thanks, John. So, as evidence of that, just thus far, since the QMSR came out, we were able to obtain, some 483 metrics. And here, you know, no surprise, corrective action, that was, on that, complaints. Supplier controls, production service provision, were all on those trends from the previous years. But now, thanks to ISO 1345 wording, we have all new categories for companies to get 483s. Including product realization, risk management processes not documented or inadequate. So this means your actual, risk management around your product itself, so think ISO 14971 here, is now the top, the top offender in the 43s that are being issued under QMSR.

And then here's, the surprise one, I think, to most of industry. Now the FDA is able to write 483s against the risk-based approach not being applied to the quality management system, meaning that there were evidence that the decisions were not risk-based. And that the decisions did not interlink with… between related QMS processes. So I happen to… to know from some conversations I've had with some inspectors that this risk-based approach is also going to trickle up to culture of quality and top management. Which is mentioned in the QMSR three times, and in the inspection model 3 times. It's the culture of quality. And if the FDA sees that your interfaces between your quality management system are not working properly.

then that means you don't have a functional culture towards quality, or a positive culture towards quality. And then that all ultimately resides on top management.

Here, I think this is also worth pausing on and making a note. So, EU notified bodies, audit reports work with the same frequency, this topic, and, both the FDA and EU now are enforcing this, but the EU has been at it quite longer due to ISO 1345.

So those who have undergone ISO 1345 audits will be more prepared to answer those questions, but even underneath the ISO 1345 audit, I have not seen it be so articulated as… as it's starting to be with the FDA. So that will be interesting to see how those trends progress. So, this is how the FDA sees their subparts and how they see them submapped to an ISO 1345 clause. This came, like, right out of one of their things. It's not very clear or traceable. But then they have 5 key differences that are… that are around, like, UDI, 21 CFR Part 11 for signatures, additional reporting requirements.

Part 803 and 860, and then, labeling and packaging control. But the devil's in the details, because you have what is regulation, then you have what is expectation, which we'll talk a little bit about during the course of this presentation. And then, where your low-hanging fruit lies is in prescription, because ISO 1345 is much more prescriptive about which procedures you need, what information they need to contain. Specific verbiage that inspectors and auditors are looking for. So, you know, if you're looking for where to start to get some quick wins, it's in this prescription.

And then start understanding the expectation around those, like, where are the notes and other references that the FDA included in the QMSR comments? And then all of that's gonna roll up and help you understand the regulation. So, the bigger picture here is that you have all these interlinkings between the standards. the notes, the expectations, etc. And part of the reason why we got here is because industry has largely ignored the preamble to the original QSR that had a lot of this content in it. So, you have to have 9000… ISO 9000, because we need a set of definitions that's referenced within 13485.

The FDA is clear that, you know, if you want to understand where in ISO 1345 it says risk related to the product, then you need to know ISO 14971. Similarly, the comments to the QMSR said, if you want to understand a specific sub… what a specific clause means, then you need to understand the notes. Now, we're not codifying any of these, these are just what we expect when the standard says that. Then, there is the Practical Guide to 1345, which is about 200 pages longer than the actual standard. I don't know what part of that they thought was practical.

And then you have the QMSR, and you have the, I think almost 90 pages of comments to a 10-page regulation that tell you what they really mean behind, their… the new regulation. And then there's a bucket of about those 4 or 5 things that they have additional requirements for that they don't think that all of this together is enough to, address their… the controls that they feel is needed and appropriate. This one's fun. So, this is a white paper that was up on Amy for the longest time, and it was free. And when we were just going through this presentation and double-checking our hyperlinks, they have taken down the free version of this paper.

We have… we pulled down and loaded a copy years ago, and I think we even have it marked up, about things that were of interest to us. But if you would like this free, source, comment yes, please, and we will make sure we get it to you. Or put Amy, yes, please, so I know which, which thing to, to, to give you. So, again, this is the comparison that they did between the original QMSR, QSR, and what is now the QMSR, and FDA actually, sat on, the writing committee for this paper. Now, they do have up this technical information report, TIR102, that is almost $400 that maps the applicable regulatory requirements referenced in ISO 1345 Quality Management Systems.

So, it's similar to the free one, but it has a lot more depth, and there's more, writing and discussion around the differences. So, in, section 4.1.2 in the general section of ISO 13485-2016, this is where it first introduced that comment of a risk-based approach around the quality management system processes themselves. So, this is distinct and different from product risk management, which is covered under ISO 14971. So, this is how you make decisions, throughout your quality management system and how they interact.

Here as well, Michelle, the EU doesn't just codify, iZone 14971 directly either, but Annex 1 GSPR and Annex 14 require risk management per recognized standard. And in practice, that means ISO 14971-2019, because the argument is… alternative is arguing equivalence with a notified body, and that's just not a fight you want to pick.

Exactly. All right. Then, again, the next place that this really hits is if you demonstrate the lack of a risk-based approach throughout your quality management system, then you have a breakdown in the culture of quality itself. So, leadership has to actively own quality and messaging and communication throughout the organization. And then risk has to drive your decisions across the QMS. This includes your complaints, your CAPAS, your feedbacks, your post-market data are all connected, and they need to be living and feed back into things like design and usability and risk management.

And then, they need to be proactive, not just reactive. There's going to be an increased expectation around preventive action instead of corrective action. And then, when the inspector or auditor to come, the system should be able to explain what happened, why it happened, and what changed. To address it.

So, in… also here to note, so the EUMDR and ISO 1345 were always auditing management reviews. And, for that reason, it, it instilled the concept of management responsibility and with the concept of the PRRC in organizations under the EUMDR and proactive and reactive PMS. This is something that, CE marking, companies, will be more familiar with and easier… have an easier time adapting to.

The PRRC is a person responsible for regulatory compliance in the EU.

Thank you, sorry.

So, if we look at inspection methodologies, this is the FDA's quality system inspection technique. So, this is how, systems were audited underneath, that QCID approach. Management was at the center of everything, because the FDA felt like they were responsible for everything. But then, when they came out with a new inspection methodology. They said, okay, if we look at this, patients and users have to be at the center, and risk-based approach and product risk management has to be the ring around the patients and users protecting them. And all the other elements of the quality management system feed… should feed directly into that risk management and risk-based decision process.

And therefore, feed into given patients and users A more, a safer product and experience. So, do you still think you're ready? We're about to dive into the specific subsections. So, this might be a good place, Sean. To put the questions. Okay, we have, what best describes your organization? How prepared is… do you feel your quality system for FDA inspection underneath these QMSR inspection expectations?

And what is your most urgent risk heading into the FDA inspection under the QMSR? So these are going to be really… Interesting responses here. While you guys are finishing that. We'll go on to design controls. Again, this is one of the FDA's top 43 items year over year. Well, where did all this expectation around the design controls come from? And it's because the FDA was trying to mitigate recall frequency by increasing the likelihood that the product was safe by design for its intended use. When they went and looked at their, recalls, 44% of them,

In just a short period of time, had, could have been prevented by adequate design controls. And the most frequent causes for those recalls were related to design, software, and nonconforming materials or components. So this is why the FDA issued the design controls in 1996 as a part of the, QSR financing tool. So now, what has changed under the QMSR? Well, we have a major shift in the notes section to ISO 14971. It also includes planning of product realization and specifically customer requirements into the design planning phase.

And then there are also more boundaries around design changes, including its impact to risk management, and the parts or processes that are already delivered and in the field. And so, though the core of the design control requirements remain the same, organizations have to ensure their procedures are updated to reflect some harmonized terminology. And to be more clear about how they're expecting, fulfilling these, these requirements, specifically within the ISO 1345. So, in terms of terminology, there are some… some just classic terms that the FDA has said, that they are not necessarily using that particular term anymore underneath the QMSR so that they align with ISO 1345. One of those is the design history file.

The design history file is a compilation of records which describes the design history of the finished device. It establishes and maintains the history file for each type of device within the product family. And then it contains the reference of records necessary to demonstrate that the design is done in accordance with the quality plan and the quality system requirements. So, if you think about You know, it in turn… in terms of, say, cooking, and you're trying to develop a recipe, the design history file is the… kind of the story of how you got up to this one repeatable recipe. And so then, the DMR, Device Master Record, is the compilation of records that has the procedures and specifications for actually manufacturing the finished device. So this is your,

recipe itself. This is how you… you go get your cookbook out. This is… you open it to your DMR for this particular product, and it tells you exactly what's need… needed and how to make it. So, both of these terms are, kind of, as individuals going away, but the DHF and the DMR together work to, establish what the, the 1345 standard is calling the medical device file. And so what we have done is just update all of our customer procedures to spell this out very clearly, that, we are not necessarily changing

these, terms themselves, because they're so embedded in so many documents and so much history, that we're just rolled together that they make up this MDF. Don, do you.

Here's…

Anything to talk.

Yeah, I wanted to say, so, in Europe, the EU, the DHF maps to the EU technical documentation under the NX2 of the MDR, And in the EU, they're not separate files, so it's one integrated technical documentation, and I'd say a critical difference is probably that the EUTD doesn't just capture design history. It's a living document, and it has to incorporate PMS data, PMCF results, and, you know, updated clinical evaluation, and it's throughout the product lifecycle. Yeah, notified bodies include TD in the surveillance audits and unannounced audits, so linking the DHF and the DMR already.

Oh, Rick. So, if we take a look at some of the QMSR comments relevant to this, the FDA said, and, you know, kind of backing up, the comments of the QMSR are effectively the new preamble, just like the QSR had that preamble that had all of their comments. This is the preamble to QMS art. So the FDA says, that technically, that it's, that you do not have to have an independent reviewer in every design review anymore. And… that because the QS regulation does not include an explicit requirement that each stage of the design review must include an individual who does not have direct responsibility over the design stage being reviewed. So, they… they said that that does not

That if they feel like it poses, undue resource burden on small companies. But it's still best practice, I feel. I think we are keeping individual design reviews as part of our process, or at least making it It optional, but still, like, a part of your design plan template to consider when to incorporate somebody that is, independent and objective. So, where to start with design controls? Well, it's kind of where research ends and design begins. It's in that spot that's right after feasibility, and proof of concept. And then it's prior to the start of an investigational device exemption. And then also it's a mechanism of change and revision control to commercialize product.

So that's some of the big things to watch out for. Design controls, now we'll move on to risk management. So… The QS regulation, design validation is where, shall include… yeah, the… okay, so in the QSR, This is the only statement that they had about risk analysis, about risk at all. Design validation shall include software validation and risk analysis where appropriate, so it's confusing about where… like, are you modifying software validation? Like, is the risk analysis go with software validation? Does it stand alone? What does it mean? Why is it only a design validation section?

And then they have the term, where appropriate. But that really means it's required unless the manufacturer can justify why you did not need to do a risk analysis. It's almost always appropriate to perform a risk analysis, and to perform the initial risk analysis during early user needs and design inputs. So, and… but again, if we look back to the preamble of the original QSR, comment number 83 in that document says that risk analysis identifies possible hazard, including use error. Now, this is back in 1996 that they said this. Calculate risk under normal and fault conditions, determine risk acceptability, risk on… reduce unacceptable risks, and ensure changes do not introduce new hazards or risks.

So, therefore, you can tell in 1996, when the FDA used that term, risk, that one time, they really meant risk management throughout the entire, life cycle of the product.

Here as well to note, the concept of where appropriate was, an MDD error language, and the EUMDR completely dropped that, so, it's presumed that it's required.

Thank you. So, more of the comments that kind of give you a little bit of insight to what the FDA is thinking. And this is one of my favorites. FDA does not, in this rulemaking, incorporate ISO 14971, or any of the other standards. but acknowledges that these other standards may be helpful in understanding application of the ISO 13485. So, again, we're not codifying it. But if you want to know how we're going to inspect you when we come there, and I… you really need to understand ISO 14971 and have something that looks awful close to it.

And this also opens it up to all the other standards that are referenced in 1345 for FDA to expand its expectations, too. And I have even seen a warning letter to a fairly large company. That said that they, their procedure said that they complied with ISO 14971, and it was clear that the inspector understood ISO 14971 better than they did. And just ripped them apart in what ended up being a warning letter against their quality system, and specifically their risk management system. So… Anyways, that's the one where I see people push back a lot, like, but it's not a rule. Okay, okay, you're gonna have that conversation with the FDA? Good luck.

There as well, and it's… as you said, it's voluntary official under QMSR, it's not codified, but, for the EUMDR, it's harmonized and effectively mandatory. So, compliance with ISO 14971-2019 gives a, presumption of conformity with the relevant GSPR requirements, so, that's also not an argument you want to have with a notified body.

So, it has been an FDA-recognized consensus standard for, quite some time. So, the FDA… this means that the FDA is familiar with it. And… and that's what they're trained to, and how they're gonna inspect, too. So, and this other one, F… FDA received several comments regarding the role of risk management in the QMSR, and FDA disagrees that it has changed its primary objective, although the integration of risk management principles throughout ISO 1345 Does not represent a shift in philosophy. Because the shift in philosophy, remember, it was in Common 83 from 1996.

So that's where they're like, okay, this is really not new, this is what we wanted all along. The explicit integration of risk management throughout the clauses of 13485 more explicitly establishes a requirement for risk management to occur throughout the QMS, and should help industry develop more effective total product lifecycle systems. So, again, they're getting back to they expect to see your quality management systems interacting, talking to, and feeding each other. So, in our classes, we go through in some detail about how each design phase interfaces with which activities you should be doing, at that phase, and which usability activities

Feed those risk management activities throughout the design life cycle. So that is, one of the areas where we go… where the class, like, really takes a deep dive into how… how it does all this interface, and what does it mean in… in your records that FDA's going to expect. Sarah. Okay. Management review. Now, management review is, classically not been underneath the scope of anything FDA was allowed to review in an inspection. But now, it's free game, because they think that all other global regulators look at it, that there's no reason that they shouldn't be able to look at it as well.

So, management review is really like hunting on a baited field, because you can sit down and read the management review, look at the data, and then trace backwards from there what did or did not feed into it? What did they not… actions did they not follow through with? So, under QSR, they were required, but the requirements were vain, and they weren't inspected. In the QSR, the… it was very brief. It was things like review at defined intervals and document your results. It had no specific detail on inputs, outputs, or structure that it needed, and it had a lot of room for interpretation.

So, to your point, Michelle, so, when I was auditing, or when I'm auditing a client during internal audits, it's the first place I look, for an ISO 1345 audit. The management review has always been substantive, and notified bodies have been auditing those records since 2004. So, EU companies will be much more prepared, when, when, having a QMSR audit on-site.

So, now QMSR is aligning with the 1345. 1345 has very specific inputs and specific outputs that you have to capture in your notes, in your minutes. And your presentation. And this is, they're going to review how these management reviews support quality, and again, they have to have access to review the records and all of the data that fed into the management review. So…

Cheers.

Go ahead, Bill.

Go ahead. Here as well, I think the management review is the opportunity to bring in the culture of quality, and it illustrates how your organization is functioning from upper management down into the organization, and you see how your processes and your QMS are working and effective.

So, in 1345, this is your list of inputs, that is very prescriptive that you have to have. But there are a few things that we feel like if you put in these small things into your management review, it turns your… the utility of your management review into much more. Than those basic inputs in the, FDA. So… so add in a little Adding a little more will actually, help you, demonstrate compliance in an audit. And so, those things are, of course, the new and changed regulations is a big one that people are not used to. But then, in our secret sauce, we have got some, around some of those key 43 areas that we feel like are…

You know, you add a little and you got a lot more mileage out of them. And how to document certain activities, especially for smaller organizations. So… Kappa. That's a big one. So then, you know, Kappa was captured in Part 100 of the 820. It required a procedure, it required quality data analysis, root cause investigations, corrective and preventive actions, and the effectiveness verification. So it's fundamentally similar inputs, but it has some additional requirements. Of course, we're bringing up a risk-based approach here. And ISO has a little bit more of a separation between corrective versus preventive action.

And then they reference… you have to look at, clause 8.4 for the analysis of data, because, CAPA should feed into that process. And now, and then this one is the interesting one, the dual meaning of the word correction. Correction now has two meanings. It means, like, whatever your basic kind of, Quick fixes for whatever it may be. Say, maybe over-labeling or rework. But, it also means if the product is in the field, and you do any of those active actions, then that is a field correction that is an activity you have to report to the FDA. So you have to make sure your CAPA procedure

captures both meetings and definitions, so that if these activities happen to product outside of your control, that, you are following the correct reporting procedures to FDA.

Here as well, Michelle, the EU has much more prescriptive and formal timelines, so, this is also captured in CAPA processes, so if a field safety correction accident follows from that, that should be documented as well, so the EU notified bodies have been looking at this for years as well.

Yup. So, now corrective action, preventive action are kind of, split. So, now preventive action is something where you should be looking at tracking and trending. And saying, hey, this isn't a problem yet, but we see it's moving towards, say, maybe an upper control limit. Or maybe a new regulation comes out, and you could open a new… a preventive action to make your implementation plan, for compliance to that new requirement. So before, this is the… the FDA took this, like, okay, this is your corrective action, and then you looked around, and how could you prevent it in other places?

But now, I know ISO auditors are expecting to see a standalone preventive action when they come to see that you are proactively looking at data from your quality management system. So, your Kappa team should be cross-functional in nature. You need to make sure it includes the kind of periphery groups, like marketing, and engineering. Excuse me, and, and that it's cross-functional, and that you've got, type, top management involved as well.

There could be a lot of inputs for what could qualify as a CAPA, and you should have a CAPA team or a review board that's looking out for these particular, breakdowns. So, gathering evidence, the ISO 1345 is very clear about certain areas that you need to look for that can, or in under the QSR, these were all the areas where it specifically said that you needed to look for, data that could trigger opening a Kappa. But under the QMSR, we have about a half dozen more places where it expects the data.

to be fed into the Kappa system for tracking and trending. And so for CAPAS, that's the ones we get into much more detail about what they are and some ideas about how to do them. Complaints. This is another big one, because it's not entirely captured underneath the QMSR. So, now we have 1345, Section 8.2.2, but in addition, we have had… we have extra requirements for complaint records that are held under, 21 CFR 820, New Section .35. So, if you are compliant with only ISO in terms of your compliant procedures, and you're not considering 21 CFR 820.35, your procedures are going to be considered inadequate.

So, under QSR, the definition of a complaint, Is very similar. to the definition that is found in the QMSR. It's similar, but not exact, because we have extra things specified here that were not specified in the QSR, mainly around usability. Around servicing, And that this definition of a complaint also overrides the definition given in ISO 9000-2015. So, what is the big picture for your complaints? ISO 1345 emphasizes on how the procedure is established and followed. It ensures activities are planned, risk-based, and consistently applied. It's basically asking, do you have an effective procedure, and are you following it?

Then in 820.35, it specifies the minimum required content documented in records. It ensures traceability, accountability, and evidence of compliance. And basically, this is taking the approach of, can you prove it with complete and compliant records? Another interesting idea that's captured, within the complaint discussion, ISO 1345, is the concept of feedback. They do not define feedback. But they do specify that feedback is necessary to identify improvement opportunities that meet customer requirements, which gets back to your design planning activities that's supposed to include customer requirements.

So, you know, there are some different ways that, you know, companies are tackling this, such as trying to get surveys or, you know, track things that are said on social media. Remember, positive things count as feedback as well. So this is going to be interesting to see the take the FDA takes on, this one.

Here in the EU, it's also very important, the concept of the proactive and the reactive PMS that's embedded in the EU MDR Annex 3, and it mandates that it has to be a two-track system. So, proactive PMS, as you mentioned, it's data you go out and find. Literature, surveillance data, clinical registries, user surveys. And PMCF studies, which is a common concept, in the EU MDR. And, so, feedback is, is supposed to be positive and negative, and that's supposed to feed into your device life, device lifecycle and product life cycle, and how you address That feedback.

Yep. So here's where the… the place that it talks about, Part 803 of the chapter, And that was in control of records. So now there are 3 places you have to know to look at for a complete and effective complaint process. You have to look at the QMSR Part 35, then you have to look at the ISO 1345822, Then, because 820.35 references Part 803, then Part 803 references recalls in Part 806. So it's… it's easy to maybe miss something if you're just looking in the QMSR and ISO 1345 for what your procedures have to contain.

And in the EU, all of your children have to be treated equally, so none of the three is secondary or optional, so that's an important thing to think about.

And then you have all these other, things that your complaint process should feed into in terms of, reporting, UDI tracking, etc. So, this is, again, kind of a bigger scope than you might have had in your complaint recall labeling procedures previously. So, what can you do? How do you stay afloat here? Well, continue to monitor those 483s, and this is the best insight into how the agency is interpreting its requirements and what the trends are. Invest in resources that Amy Whitepaper, again, send a message. Yes, please, Amy. Amy, yes, please, something of that nature, so I know to email it to you.

It's a great resource. The free one, obviously, is a great resource, but the paid one is also very helpful. Get all the guides and the practical guides, to ISO 1345, 14971. It's explanatory standard, ISO 24971. And don't forget your personnel or resources, too. Get them training. It's, you know, particularly helpful, I think, is the implementation strategies I share in my classes. And then assess the connections between the quality system processes. How well does the complaint team know the risk management team? Like, are they on good footing? Can they hang out and go get a beer together? Like, it… this should be a close-knit working cross-function team.

And then always be looking ahead, like, what is the FDA thinking? Where are they going? So I'm not, you know, at the back of the bus when these things start happening. Yep, and in other news, FDA has announced, like, a one-day inspection method that's supposedly helping them make risk-based decision-making in their inspection strategies. So that is still fairly new. They've only done 46 of them, so I look forward to hearing from somebody about what that process was like. Then there has also been a recent warning letter for people who were inspected prior to February 2026, when they were supposed to be compliant to QSR, and FDA said that they expect, now that your corrective actions are being taken.

after February 2026, that your corrective actions are clear, how you are now fulfilling not only the QSR elements that were delinquent, but your QMSR, new requirements as well. So, we've got programs to help you with all this, Learn Lean REQA and Lean REQA Launch. So be sure to check those out if you feel like you need extra resources or support. These are all of the classes that we offer individually, and then we have a discount on the whole bundle, so, type, ready or not for your code for 15% off.

So, Dawn… Dawn is now gonna, give you a teaser for the webinar that she's gonna do, I think, within the next month or so, on the state of the EU union. And so, Dawn, how are you gonna… what are you gonna enlighten us with here?

Sure. So, I'm going to talk to you about the state of the EUNion. So, and if we look here, here's some four important topics, that I'm going to talk about, and I've presented it as a regulatory weather report for the EU. First and foremost, we have the MDR 2.0 with shifting weather conditions. And, we don't have the MDR 1.0 in full state of play, with not all 6 modules of the UniMed up and running, but, there was a communication from the Commission, which was released in December 2025, It's still in legislative procedure, and, we're hoping for adoption realistically late in 2027. So, be on the lookout, but, don't take it as rule yet.

Has some important regulation changes, for software. For instance, Rule 11. It starts now at Class 1 instead of 2A. This will be very significant for SAMD devices. Surgical instruments are always… now, reusable surgical instruments are always Class 1. The, safety and summary and performance safety and clinical performance, the SSCP obligation has been narrowed to devices requiring systematic technical documentation assessment. And there's some news on well-established technology, a category that's been created for proportionate conformity assessment. So…

when we look at UdiMed, the weather is partially cloudy. We have some news. The UTIMED Section 4 modules are now live. That is the actor registration, the UDI device, notified body and certificates, and market surveillance. The active registration module is a prerequisite for any UDMED activity, and without it, you can't submit the PSUR, or register devices. So, new devices since May 28th must be in UDI device, module, first, before placement. And the next step is legacy devices on the market before 28th of May have to be, on 27th of November 2026 to register.

So we're still waiting on the vigilance and PMS, and clinical investigation modules to have the full state of play, so this is what I meant by MDR1.0. We haven't even seen if that's going to work out well, but we're moving on to MDR2.0. Now, the next one on the upper right is another, partially cloudy. It's an improving outlook. It's a special favorite of mine, having experience with the FDA Breakthrough Device Program. So the main advantages of the FDA Breakthrough device program is the early interaction with FDA, and I'm curious to see if the EU model will be close to similar. Because besides the boasting rights to attract VC and potentially accelerated CMS reimbursement, the main advantage of the program is that you have direct feedback with the FDA in alignment.

And as notified bodies don't consult, I'm curious to see what the structured dialogue is going to look like. So… Then it brings us down to the right, where we have stormy weather. So, according to the MDR 2.0, review timelines have changed, but the margin for error hasn't. So, with the 2026-977 in force, it makes notify predictable time… notify timings predictable. Per February 2027, but it doesn't shorten the queue in order to get a notified body. So, getting a contract with a notified body is still a bottleneck, and it's not going to change with the transition deadlines. So, those are the things that I'm going to talk to you about at the end of the month of July, and I'm looking forward to updating you with more details. Stay tuned!

I go. Free templates on our website. And then let us know how we can be helpful, and again, I'm gonna… go through the Q&As when we, get the summary of the webinar, and… You'll get these slides that have all of your resources, you'll get the slides and the answers to your questions, and that white paper from Amy, if you so wanted it. So, thank you for joining us, thank you for your time, And, check out the classes for that kind of in-depth implementation ideas.

Yeah, I dropped the class links into the, chat, so you can purchase them as a bundle or individually. The code is there for the 15% savings, and I hope you all enjoyed today's webinar as much as I did. I'd like to thank our speakers, Don and Michelle, for, spending so much time preparing this and putting together an excellent presentation, and I'd like to thank all of you for your time and attention today. I hope, you, Have a great week. Thanks so much. Bye.

Thank you, everyone, bye!