FEEDBACK AFTER 3 MONTHS OF THE NEW FDA QMSR IS IN PLACE 

If you are located outside of the European Union, the United Kingdom and or Switzerland, then you need an authorized representative. So, I have a good news. You have find it with EasyMedicalDivision. And if you are also in need of an importer in Europe and in Switzerland, then contact us definitely at info@ EasyMedicalDivision.com. And I'm sure we can help you. Welcome to the Medical Device Med Easy Podcast. I am Munir Alazuzzi, a medical device expert specialized on quality and regulatory aspects. My mission is to help you learn how to place a compliant medical device on the market. For that, I share with you my experience and the one of others on this podcast. Are you ready for your dose of regulation and standards today? Okay, so let the show begin. Here is Munir Alazuzzi from EasyMedicalDivision.com. And today, we will talk about QMSR. We talked about that already in January, February, because we had an episode about that, where I tried to warn you about the arrival of QMSR, which is the new FDA tool, if I can say, a new FDA quality system that everybody should be using since February 2nd. So after three months, let's try to understand what happened on the field. And let's mainly check if there is any surprises, if there is any, what can be the advice that we can get from people that see what's happening there. And for that, I have with me Matangi. Hi, Munir. Thanks for having me here. You're welcome. And thank you for joining us. Thank you for making this episode where you would be really trying to share mainly things that you have noticed about QMSR, because I think it's important for people to understand more about that. Not only getting the kind of theory of what is QMSR, but now the practice a bit more, so many what people are looking at. But before that, can you make just an introduction of yourself so that we know more about you? Of course, yeah. Okay. My name is Matangi Strinivasan. I am currently a quality assurance manager. I work for Abbott Vaskiller, when I manage quality systems for class three devices. I have a work 12 years of experience in both quality and manufacturing. Initially worked for diesel engine manufacturing, switch to semiconductor industry and now to medical device industry. But throughout the industries have always been in quality and reccompliance. So I have a lot of experience working in different industries. I have three masters degrees. I went to school in UW-Madison, and in my masters in biochemistry, then went on to do my masters in manufacturing systems engineering. And I also hold an MBA from Open University. In terms of industry certifications, I'm an ASQ certified quality auditor. So I understand the auditor sign of things. I'm also a certified six sigma black belt. So I understand problems solving your dematmetrology, lean manufacturing, all of that very well. I currently work for Abbott, been here for more than five years. And I've been in the industry for about 14 years now. Great. So a great CV. And I hope it will help us to, if I can say, find the solutions for maybe manufacturers that are listening to us on how to be perfect at QMSR. What are the traps that they should not go through? So yeah. But maybe just to start because we always have some piece of some auditors that are maybe listening to the podcast and maybe we start from beginning. They hear those acronyms like QMSRs. What are we talking about just maybe for beginners like this QMSR for beginners? Of course, thanks, man. Yeah, I'm going to talk more from an industry perspective of things. So it's not going to be theoretical. It's not going to be textbook language. But I'm going to try to explain in very easy language just based on your podcast. Really love it. Thank you. So I'm going to try to. Yeah. So I'm going to try to make it very easy. So QMSR is FDA's quality management system regulation that as you mentioned, it became effective Feb 2nd of 2026. And it replaced the old QSR, which was the quality system regulation that almost manufacturing industries have been following for close to 30 years now. Yeah, I think before I was born with no, I was born with no. Oh my gosh. But before I was in the industry, I myself. Yeah. Yeah. So in short, what's the difference? Right. I think you mentioned it really well in your previous podcast on the theory of QMSR. So FDA decided to incorporate ISO 13485, which is the international device product quality standard directly into us law. But here is the critical path for manufacturers. QMSR is just not renaming QSR into QMSR. It's a fundamental shift in how FDA thinks about quality. For example, under QSR, quality was organized into different subsystems. We used to have from for people who have been in audits, right? You kind of know that we always categorize quality into manufacturing controls, management controls, design controls, Kappa production and process controls. You'd have like the auditor looking at each of these in the auditor agenda. You could almost treat them as separate boxes or in manufacturing language. We call them silos. What happened with QMSR? It completely changed that. Now, FDA expects quality to be integrated across the entire product lifecycle. What does this mean? It means design, manufacturing, supply chain, post-market surveillance. They're all connected now. And risk management isn't just design activity that R&D does. It is continuous and it needs to happen across the entire product lifecycle. What does it mean from a manufacturing perspective? So that's the theory. What does it mean for manufacturers? It means you can't compartmentalize. You cannot have silos. When your R&D team makes a change, manufacturing needs to validate it. If you identify a manufacturing risk, then design needs to know about it. Similarly, if you take the example of post-market surveillance, right? If your customer complains data, suggests the problem, it needs to feed back into your risk assessment. And FDA auditors want to see that systems based thinking. It's not a checklist anymore. The other major shift between QSR and QMSR is that this is kind of critical. So the way FDA does the inspection that's completely changed. So earlier, they used to have QSIT, which is quality systems inspection technique. It was a small book that we approached. We looked at it and I remember this book. Yeah, yeah, yeah. I think I got it as to like. I can have one somewhere here. Yeah, yeah, yeah. I got it in my first job. They gave all of these QSIT pam flex to people who were joining the audit team for the first time. So I remember saying that. So now FDA retired the QSIT and they implemented a new compliance program, which is more QMSR based. For my number notes here, it is 7382.850. I've seen it so many times I remember the number. So, so many, many here. When you say they're retired QSIT. So it means that they have a new program, the same a new pamphlet book for that like the 7382. Yeah, yeah, it's a new it's more it's a compliance program. You can look through it in FDA's FAQ section. It talks a lot about that. What it does is it is more risk based and it's more product life cycle focused. So they really emphasize risk management across the entire product life cycle. And based on this and based on this new compliance program, auditors are now asking really hard questions. Like I mean like really hard questions and it's different for people who haven't seen this type of inspection before. So, what if the auditors want to do now is they want to actually listen to your actual decision making. They want to understand that you looked at the data, you made decisions and these decisions were indeed risk based. They're not checking. Do you have a procedure for this? Do you have a procedure for that? No, that's not the way they're questioning anymore. Yeah, I remember participating to multiple FDA inspections. For example, when we're working on non-conformities, they just ask me provide me the list of non-conformities. We pick 405 and they have this QC statistics. We say if you have this you have to pick 11 if you have this. Right. So then we pick the 11 non-conformities. Then we are sharing the first one. He reads it is what it is, etc. They say, okay, next one go next one go next one. It was like, I was like, it's just a check. It's not 305 so it was like, oh, it's only that you just look at what we have one that is it's completed correctly or not. I don't know. But there is no as you mentioned connection between these two. to maybe what was done after that we opened a Kappa for that we have made this, we have made a recall, etc. It's mentioned on the NC maybe or maybe on the NC say we open just a Kappa but they are not like following with all these. - Right. - With a Kappa itself, things which is, if you never have that before, it was like, really it's that's only, it's okay. - Yeah, yeah, yeah. So companies who typically have like five days of audit, right, initially in the first day, if you're auditors asking something about design controls and the fourth or fifth day they want to see post market surveillance data, now they're going to make the connection. Okay, you showed me this in your complaints data. How did you make sure you assess the risk in your design phase? How did you make sure that the defect or the problem didn't occur anymore? They are going to make the connection. - So there was also something that was surprising when I was doing these inspections in comparison also to the ISO is about blocking out the text of things. So for me, it was also strange. Why are you blocking out all this management review and channel or did et cetera? I said, why? Because they don't have the right to look at that or whatever I don't manage. - Exactly. Yeah, no. - It's not possible anymore, I suppose, now. - No, no. So right now with the new QMSR technique, your internal audit records, your management review records, even your supplier audit records, everything is fair game. Auditor can ask any information because they wanna see that you really have this risk based approach when you qualified a supplier, they wanna make sure that you actually use that risk based assessment. And they wanna make sure, say, if you're looking at post-market surveillance, if you're looking at complaints data, and if you identify a failure, they wanna make in a critical, say, raw material, right? They wanna make sure then when you assess the supplier, you indeed looked at that. - Exactly, yeah. So no more blackouts for people. No more blackouts. Every information as fair game, every internal records FDA has the right to look at it now. It actually even purely states in the FAQ section of the FDA website. - Yeah. So as we said before, it's been now three months, around three months, we started this QMSR. - Yeah. - Did you have maybe any feedback or how it went? Is our people complaining? Is everything okay? Or is people like, surprise what's happening that it's completely different as well we didn't know about that. I mean, do you have some feedback? - Of course, yeah, been in the industry for a while. So I do have some feedback. Sorry guys, it's not good news. It's not rosy. Honestly, I think most manufacturers are struggling. So I'm gonna talk through some data and statistics here. But overall the feedback I'm hearing from the industry, it's consistent. They underestimated the scope of QMSR, I would say. Because a lot of companies thought, hey, I saw 1345 certified, which means I'm QMSR ready. Now they find out that they're not. I was looking through some industry surveys trying to gather data. And I found out that the surveys clearly says about 54% of device manufacturers are moderately or not very well prepared for QMSR. It's more than half the population. - 54% are not ready for QMSR walls. - Yeah, yeah. And then I think they also did the breakdown based on audit reports. And the service is that 46% of reports are okay, prepared, 36% are moderately prepared, 18% are completely unaware of QMSR. - Okay. - It's scary, right? So there was some work maybe for me then to reach out to them and help them for these kind of things. It's just great. - Yeah, yeah. Yeah, the key is being ISO 1345 certified, does it mean that you're prepared for QMSR? It's a completely different systems based approach. And obviously, it's three months almost since the enforcement of QMSR. So obviously on FDSN, they are actively conducting inspections under the new QMSR framework. And according to an industry survey, again, large metric companies are seeing an uptick in the number of unannounced FDA audits according to the current trend. - Yep. So I suppose we will also see some warning letters popping up where we may be have some view about what was the issue that they have identified. - Yeah, actually on FDS website itself, they have their warning letter statistics and it says in just two months, just in February and March, 2026 after QMSR, the issue of nine warning letters already. - Okay. - Which means, yeah, enforcement is happening now, right? It's not theoretical anymore, it's not hypothetical, it's not like we're waiting for it. And these letters are actually using QMSR language instead of the old QMSR language. So it's gonna be a good source of information for people that want to also to learn about how an audit went, what are the issues? Because if they put these issues on the warning letter, it means also that if they find them with your company, they will also issue warning letter for you. So it's many important for them also. - Yeah, we always wanna learn from other companies, make sure that we don't do the same mistakes. - Yeah, exactly. - And we can also even look at like public sources, right? If you guys really wanna dig into the data, you can look through the credit card right now. And there is some really scary language, wanna say, people say the codes are kind of red, are like we're trying to really restructure our DHA, we've spent months doing this now. And we're really trying to find out where our old documentation exists. And there are a lot of forums that talk about the way auditors are questioning. They're like our inspectors are asking questions with Eli, haven't even like heard of before. Now they're asking to see management records, they're asking to see supplier audit records and all of that, right? So it's something that they are discovering. I suppose if they were doing ISO 1345, they were already knowing that this can happen. But if they have never done ISO 1345 before, or MDSA because it's nearly the same. So then yeah, it's a completely new way of auditing and I suppose a lot of them are like, wow, what's happening there? It's, yeah. Yeah. - It's true. - And in terms, so you said they did, there are some forums that are discussing about that. So is there some, should we share some links maybe, or two people to say, here are maybe some forums, so you can see some feedback or? - Yeah, yeah, of course. Yeah, I can send those over. Yeah, mostly like very like clear public information like Reddit forums. Yeah, LinkedIn. - Because I suppose I suppose also for those manufacturers, if they want to ask questions, they can also maybe go to those forums and check. These are asking questions to those forums. So it's always funny. - It goes forums and you are looking at it and looking at what they are asking questions. So the answer that provided, so it's funny to see the problems that people have and say, oh, I didn't know that this was a problem. So I mean, you know, it was any problem again. So now it's clear that for some companies, some basic things that we were doing already before are really becoming big problems for them. - Right, yeah. And obviously you have to spend a lot of time, money, engineers, resources to get all that information, get things in order for being QMS already. Okay, and mainly those, I suppose FDA, they will be doing this inspection, they will again come back and verify that you are solving all those problems again. So the process is the same as before the QSR. So it's mainly audits issuing a 483 or warning letter and then expecting people to then make the corrections. - Yeah, absolutely. So many, do you have some cases that maybe we can share with people to say, here are, for example, I call them low hanging fruits. So things like mainly all auditors have some low hanging for the know if they ask this question or ask this thing and just by hearing the answer, they know they will get a knockoff from each year, they will get something out of it. So is there some kind of those low hanging fruit that people maybe could be aware of that's maybe to avoid that they are going to disrupt? - Yeah, sure. So I'm going to try to share as much as possible real world examples from manufacturing. So you can relate to it. I'm not going to name any companies here just based on industry knowledge. And so I'm going to talk about the most common problems that people are facing since the switch from QSR to QMSR. The first problem, which I think a lot of manufacturers face is design history files. Now design history files is just, it's a lot of knowledge that's been, that's your history, it's your legacy, right? Like, for example, let's be very specific here. For example, say your company is making class three orthopedic implants. So these are implants that are surgically placed into people's joint, right? It goes in, into the body of a patient. Under the old QMSR technique, your design history file was probably had some design inputs, design outputs. You had some risk assessment. You had some design changes as part of your risk assessment. That's your old QMSR. It was all documented. But again, the organization was not very standardized. And FD really didn't care about the organization. Now with QMSR, your DHF needs to follow a specific structured approach. And FD auditors really want to see what problem are we solving. How does your device solve the problem? And they really want to dig in deep into something like design verification. How did we verify the device works in the way we said it would work? And how did you validate it in real-world conditions, which is your design validation? The really dig in deeper into all of that. And most critical part is where could the device fail, which is your risk assessment? Where could it fail? What are we-- it's not just that, OK, it could fail here. What are we doing about these failures? How do we track it? How do we make sure it doesn't happen again? So they really want to see that kind of a thinking. Now, if you're a manufacturer, here is your pain point here. Say your device has been in the industry for five, six years. Now, you have five years worth of design history, not that you need to go and dig deeper. Are these really properly organized? Probably you had information that's scattered across emails. You have SharePoint folders. You had PowerPoint presentations. Now, you need to put everything together. You need to look through all of that, understand what was the design logic, what decisions did we make, and organize it in a way that has this unified narrative. It talks about risk assessment in every single step. That's what FD auditors want to see. They want to see the actual decision making. Exactly. And I suppose now that-- so for produce that we already manufactured a long time ago, I don't think they will be asking you to update something that is already on the market since long time, and that we have all data. But I suppose for any design that is now actually ongoing, as you mentioned before, it's like for the company that already started with the QSR process. And now they have to move to the QML size. We are being on this project since two years now. So what's the strategy here? So I can understand this difficulty here. But is there really a big gap between design historical DHF and ISO 13485, where to create a design file also? Yeah, it's pretty much the same. So again, with QMSR, it's kind of ISO 13485 that is integrated into US law. So it's more stringent QSR, I would say. So it really digs into deeper to understand, do you have that risk-based thinking? Are you asking the right questions? How do you make sure the product failures don't happen? For example, if you're looking at post-market surveillance data, it's kind of going to ask the same kind of questions. If you're looking at customer complaints, how does this feedback into your design? So all of those, I would say, it's more like systems-based thinking is what every auditor's are looking for. So it's, I'll recall the history. So many, you have to recall, it's a design story file, but it's manual. But what is the history of everything? Do we have a clear history for all the things? Do we have everything at the right time, et cetera? Is A going before B, they're going before C, or we have some scrumble of all the stuff? So many, yeah, it's-- And especially if you're having documents across, like, say, some of them are in emails, you have meeting minutes, action items, then some of them are in PowerPoint presentations. You have to kind of get everything together. And it makes it really hard, especially, say your resources moved, and you have some brand new people who are taking up the role. They have to go back and dig into all of those details. Exactly. That's what is time consuming, right? OK, so you had-- so this is the first example. Do you have another one? Of course, yeah. So for the second one, I want to emphasize on another pain point, which is your customer complaints. So we'll talk about that. And then for the next one, I kind of want to touch a little bit about management reviews, or like-- I'll talk about all the common problems. So let's go into post-market surveillance. What is the shift from QSR to QMSR? So really simple terminology with QSR used to be more reactive. So you had a system to collect complaints. You had your post-market surveillance team. They would collect customer complaints. Something bad happens, a patient reports it. You investigate, you try to solve the problem. It's more reactive, right? With QMSR, it completely flips the switch. Now you're more into a proactive thinking. You need to identify all the high risk failure modes upfront. You cannot really wait for customer complaints to happen. So for example, let's take an example of a company making neurovascular devices, right? Just giving an example here. So these are devices, interventional devices that are placed into the brain of people. Now you need to monitor for the most common failure modes. What could happen for a device that's placed in the brain, or arteries, or heart? You could have something like catheter or kinkings. You have embole complications. You can have navigation issues like all these difficult to advance, failure to advance, all of those issues, right? So you need to look at, OK, for my device, what are the top failure modes? And you need to establish a monitoring plan, a systematic monitoring plan. You need to proactively track hospital records, patient registries, look at FDA databases for these failure modes. Understand the trend. So the shift is, instead of waiting for a complaint to happen, you're more trend-driven. You're not reactive, you're proactive, you're like, OK, these are my most common failure modes. How do I make sure it doesn't happen? Do I have good controls in place? Do I have a good tracking mechanism? So all of that-- and obviously, you need to have good statistical analysis tools and resources to look at the trends and make an informed decision. So what changes for manufacturers? You need to have those systems in place to collect all the data from multiple sources. You need to analyze them. You need to make the right decisions. You need to document the decisions, because now, FDA auditors want to see the decision-making. So I suppose also that when it's the first time that you get those kind of questions, what are you doing to avoid those issues or what are you putting in place to be proactive? A lot of companies are like, what are you talking about? Yeah, exactly. I'm like, yeah, a complaint didn't happen. And then there'd be like, but you are seeing an uptake in complaints or you're seeing a negative trend in the performance of the device. What are you doing about it? That's a very valid question now. Exactly. OK. So next point about management review, you said? Of course, yeah. So that's another big pain point that I'm hearing across the industry. I think you mentioned it earlier as well about the blackout of the record and everything. So again, with QSR, management review or your internal audit program or your supplier audit program, everything was internal for-- let's take the example of management review. So for management review, probably what you did, your executive team, your leadership team met, the discuss quality metrics. You made some decisions, you documented decisions, right? You did it. But again, your FDA auditors didn't really ask for that information during a routine inspection. But with QMSR, it's very explicit. Management review records are part of your QMS. And FDA auditors have the right to ask for it. Now again, what are they seeing in these reports, right? Let's again take an example of an industry. Let's take this time, or diagnostics. Ignorantly, that's really right. Say your last FDA inspection, you did it based on your QSR framework, which means you did have a manufacturer, you did have your management reviews, they existed and everything. But necessarily your FDA auditor didn't ask for it. They were brief. Probably you just documented it, email conversations, quarterly reviews, right? But now that's not enough. And your FDA audit is definitely going to ask, what data did you use? Like show me your management review minutes. What data did you look at? Show me the quality metrics that you reviewed. Show me your capatrends. Let's see, it's not about just closing your cap anymore. Are your capas effective, right? And they want to see that you're identifying the systemic problems that exist. They really want to see the decision making, did your leadership, like was your leadership involved in decision making? Show me the minutes, show me all of the data that really led to this decision. They want to see that. And you might ask, like, I'm just giving an example here. So like people might ask like, why do they want to see it? this information, right? The answer is, say for example, again, this is an example of a company, say if you had your internal quality audit, right? If you had your internal audits, you identified a problem about your device. And then a month later, you had your management review. And if your management review did not address that issue, that means you have a gap, you have a compliance gap, they're going to ask, why did you, you had an internal audit, you identified this critical problem in your device. Why did your management review not talk about it? So that's again, like it's basically what happens with Q&MASR is if you have these gaps, Q&MASR is going to address it, Q&MASR is going to expose you to FDA and FDA is going to cite you for it. So you want to be really careful, make sure that all your management review meeting minutes, your internal audit data, your supplier audit data, all of these are connected and they actually ask these genuine questions about risk assessment. Exactly. And if I remember, I mean, on my audits usually, when we start with those quite system documents, management review, because you want to have an overview of what's happened in the last year, so they see the content of the management review, the slides, the decisions, etc. And then now they can start the audit with an eye about what happened, what's what occurred during the year, which is a good start for them also. Yeah. And it's a very valid question, like under Q&MASR they can ask, why did your management review not address this quality issue? Yeah. So yeah, it's valid. And again, like the thing for manufacturers, they're not your internal audit program, your supplier audit program, they're not individual elements. Now, they're all connected and they need to understand that. Yeah, exactly. Yeah. So this is, I think the difficult part where everything should be connected. So they will go from A to Z, and you will say, why are we doing that before we are doing just A when we finish A, we go to B, but it's not like we are connecting, they are what's happening with one another. But yeah. So in terms of now that you have maybe this feedback, this information, etc. So mainly, what would you advise to those manufacturers that are expecting maybe an FD inspection or worry about this FD inspection. So is there some kind of good practices or tips that you can provide for them to be prepared and to not be fearing, if I can say this, this event because it's always, we are always afraid when the FD is knocking at the door and say, we in Europe, we are fine because usually when they are going to come, they have to inform us in advance, we have to give them like your authorization, etc. Then they can come. So it's like three months in advance. We know already that they are coming, but I know for FD, it's like maybe one week in advance or a few days in advance that you know that they are coming. So it's like, oh, what can we change in one day or two days? Nothing. So, obviously, have some advice for them? Yeah, for sure. One recommendation, one major piece of advice I would give us, you need to first stop getting scared, obviously, and stop thinking, I know it's hard, right? And you need to stop thinking of QMSR as a compliance checklist or a compliance project. So, not that we are asking you to be compliant. It's more of, I would say, a quality system redesign. There is a big difference. Like, you need to look at your quality system as a whole. And in my 14 years of experience working with both large companies and small startups, these are some pieces of advice that I would give. The first thing is get your cross functional team together. No, you can't wait for it. FD has already started enforcing QMSR. We're already starting to see warning letters and audits happening. So you need to bring everyone together, bring your design team, manufacturing, quality, your regulatory team, your supply chain team, get them all in a room together, not separately, together. And they all need to understand how QMSR connects their work. Now, R&D isn't just responsible just for design, manufacturing isn't just concerned about right first time metrics. Quality is everyone's responsibility and they need to understand that. The reality is, if you have silos that exist in your process, then QMSR is going to expose it, FTA is going to cite you for it. So you want to have the cross functional approach. That's my first piece of advice. The second thing I want to point out is understand your documentation reality in terms of not what you actually think you have. You need to look at what you actually have. Do you have three years worth of design history that needs to be organized? Where does all this documentation exist? Are they started in emails? Are they in PowerPoint presentations? Are they in several files across your share point? Are they in one more documentation? You need to put everything together. You probably need to have some kind of a master index. So it creates this unified narrative for the FTA auditors so they can understand this whole system's based thinking. They can ask all the questions and you have all your answers right there. I suppose having an electronic quite imagined system, for example, is to let maybe they should think of. Yeah, obviously, if you're having binders and stuff, you have to really have everything together in one place. Obviously, if you're having years worth of design history files, right, design history files are just, it's not like files. It is your evidence of thinking, your evidence of decision making. And FTA auditors want to see that decision making. Okay. The third piece of advice I would give is across another pain point that a lot of people are facing. It's a risk management. Now, I think it's one of the biggest change on the QMSR, the risk management. I hope everybody say risk management is the one that maybe will surprise everybody. So, yeah, yeah, risk management isn't just I so one for nine seven one, right. So, some design space. Now with QMSR, it has to be a cross-data product lifecycle. FTA auditors want to see that. They want to see that risk-based approach. So, what you can do if you don't have something like this, I would suggest something like have a monthly cross-functional risk review meeting. It cannot be just design just R&D team. It needs to be cross-functional and you need to bring in data. It's not like, you know, just discussing, okay, what are we going to do about risk? You need to bring actual data. You need to bring your capital data. You need to bring your field complaints from post-market surveillance team. You need to even bring your manufacturing issues because obviously, we cannot wait for failures to reach the customer, right. You need to bring your manufacturing issues. Even bring in, you know, like go back to your supply chain, go back and bring issues that are suppliers facing your tier one suppliers, your tier two suppliers are facing related to this device. Bring everything together and have a unified approach. Have the cross-functional team review the data and make decisions and then they can ask, like, okay, so this problems are happening. How do we, do we need to change something in the design? Do we need to change something in manufacturing? Do we need to have more controls in place? Is that control plan adequate enough? Do we need to have more monitoring? So it needs to really document this decision-making. That's okay. Let's look at the other topic. The other advice that I would give is this is also another pain point for a lot of companies. Your internal audit program. Now your internal audit program cannot be answered. Okay, am I doing this? Am I doing that? Am I, do I have right procedures? No, it cannot be a checklist. And internal auditors really need to dig in deep. They need to genuinely ask questions to see if your quality system is actually managing your risk effectively. They need to understand what are the gaps? How do we make sure we resolve these gaps? And FD auditors really want to see, like when they're looking at internal audit reports, they want to see clear objective evidence. They want to see that you had analytical thinking, not just crossing off the checklist. So, I suppose, for the internal audit, it's a struggle, even for ISO 13485 manufacturers to internal audit money because we have to prove that we are able to find issues by ourselves. But companies are also afraid because those issues will be shown to the notified word or so to the inspectors. So, it's like, should I mention it? Can I solve it without mentioning that? Definitely, FD auditors are going to see your internal audit records. But they are going to see that if you don't document it and if you had an issue, you resolved it. Instead of the audit, they're going to be like, why did you not document it? You did not in literally the same day and how did you not identify this issue? And the problem comes when your quality, your internal audit did not identify the issue, but say was brought up in management review and your meeting when it said, hey, we have this issue and we resolved it. And then we like, you're trying to internal audit, why did you not catch it? Exactly. And then the last one, again, last but not least, management review. You need to really look at the data that's being presented in management review. So management review, just in terms of like how people do management review is different, but you always need to think of it this way. It cannot be just a compliance meeting. It is your leadership sitting together, your cross functional team, your leadership, sitting together and making some important quality decisions and these decisions need to be based on data. It needs to be based on your transit performance of the device. So you need to really look at data, have your team together, make these decisions, document these decisions because you're left here or it was going to see them. You can't really black out information anymore. Exactly. And one last piece of advice I would give is plan, really plan for it because if you're just transitioning into QMSR and you think that you're ready, it's probably not going to take you six months. It takes companies average 12 to 18 months because again, if you're looking at DHS trying to make them in a structure that's QMSR compliant, it takes a lot of work. So plan for it, do not have silos because if you have silos, FTA is going to find out with the new QMSR structure, they're going to cite you for it. Do not rush again, try to methodically plan for it, have the systems based thinking. It's more of a cultural change I would say. So definitely plan for it and have a liquid time and don't rush. Yeah, I thought I wanted to say so many. Here we talk about documentation change but at a certain point it's also the human to change because I'm always having this with maybe let's say old people I start to be old myself but I call people say oh we have already done that that way so why should we change it was working well that way, so they don't really understand some time. So many this is many the risk that people don't want to change because they don't see why. So it's why this kind of education, some pedagogy to explain people why this, why that, why we are doing this etc. And I said some time for people that are really difficult to manage in that way. I said okay then I will invite you in front of the inspector and you will answer the question because then you will see how difficult it is and you will see why we are struggling and we are putting that in place because when they don't see it they don't understand it. So it's mainly some strategy here but yeah, that you mentioned also about yeah this change management review etc because mainly here we talk about the leadership. So what's your advice also for maybe those leadership or CEO that's here this acronym QMSR so yeah quality will take care of that so it's fine I suppose if they are not on the boat with you it's not working. I understand. I've had people a lot of people ask the same question like how do I convince this to my leadership my CEO doesn't understand or my CEO is just about like you know like sell the product give me money right so how do you really explain to them okay I'll give you like three talking points here the first thing is if you're in a magic industry you really need to focus on patient safety like honestly to me patient safety is a non-negotiable and you need to think of it this way why does QMSR exist like why did FDA even bring QMSR in the first place because they probably determined that your previous the previous standards that existed they weren't sufficient enough to ensure device safety to make sure that the device is safe enough for the level that patients deserve that like we need to make sure our device is having the utmost like quality because obviously your device is probably going to go into the brain the heart arteries of patients right so think of it as if like would you really give this device to your family not knowing about the quality of it right so yeah patient safety definitely that's a non-negotiable for me and you want to think of it this way like your quality system is what stands in between FDA and patients home so you want to do everything possible to prevent harm to the patient the second thing how you can convince your leadership is FDA is enforcing it's not it's not theoretical anymore it's not some kind of a textbook theory anymore inspections are happening FDA is giving warning letters obviously your CEOs go ask what does it mean for me okay I got a warning letter you guys go fix it your quality no what happens when you get a warning letter you have to remediate it you have delayed product launches you probably cannot sell your product to certain geographies until you fix the problem you're going to have damaged relationship with regulatory agencies you're going to have damaged relationships with your stakeholders that is something major right so I want to kind of find about point this way like the cost of not doing QMSR not following QMSR is way higher so your leadership needs to understand that it's going to make some very difficult decisions for them yeah and the third yeah had had this experience with some manufacturers I'm working with where they discovered that one of their the supplier they will be using for some production had a warning letter and so my decision but they decided to say it's too risky for us we are a young company just starting on the business if the people know that we are manufacturing at that place and they have a warning letter it can be a danger for us so I prefer that we switch to another supplier instead of yeah going to do this one so it's mainly also they're coming some business decisions also due to that so a warning letter is public we see your name we see the company we see the information we see why you had some issues so if some issues are really kind of big enough to make those company afraid to work with you then yeah they will drop off and they will move to another company so it can be as you mentioned maybe for the CEO an argument to say if you are not complying maybe we can have lose some customers also yeah yeah you can lose customers you'll have really bad reputation with your stakeholders it's good to impact your business guys like that's for sure so I want to try to avoid it as much as possible exactly the third thing how you can convince your CEO CEOs and CEOs and that the huge C-suite leadership is competitive advantage right like when you're looking at business yes it's competitive advantage and if your company's implement QMSR properly then they don't scrambling during inspections their design to market timeline is very quick because your systems are integrated they're not fragmented they're not trying to get information across different sources that are not connected like everything is connected here and your supply chain is more reliable you're you're going to have you're going to have more customers because your supply chain can manage your risk effectively and your product safety is very high because you're catching problems early you're making a proactive approach based on trends you're not waiting for a customer complaint to happen so you're going to be doing business well in short I hope you need to pitch that yeah yeah you need to pitch that to your leadership it's it's a pretty easy one you have patience safety you have regulatory compliance you have competitive advantage you have business decisions so yeah you need to implement QMSR yeah I'm convinced I will so Matangi really thank you for for all this anything else to add to all this I think it's we have really here a good recipe to pass this FD inspection for QMSR any last word maybe for people that are listening to us yeah kind of what I kind of mentioned earlier please do not rush one important thing have a systems based approach you cannot have silos you cannot have your different departments working separately they all need to understand that quality is everyone's responsibility so it's mainly everybody together again like working together not separately etc which is good also for the company because everybody will be talking to you to each other also great so if people want to maybe contact you and ask it's okay for you if you want to ask you a bit more question about QMSR give them give some ideas about maybe some some experience that you had also about that yeah definitely I'll be happy so people mainly you can go on the show notes or so and you can get maybe the profile we'll put the profile of Matangi mainly for for LinkedIn so that you can reach out to her and set to her for that you like to be the podcast and then you can ask any questions obviously yeah I'm not giving any confidential information obviously I'm happy to help in terms of how do you prepare for QMSR and definitely trying to I'll try to guide you as much as possible exactly yeah so great so thanks again Matangi for all those information I hope this will help some manufacturers to pass this this inspection again if you also if the certain companies also wants to get some some advice we can also organize some meetings with them confidentially also for for that but yeah QMSR is the new low in the US so it's not like something that will be just last few months, it's really something that will maybe last for the next 20 to 30 years. So, as you might be based on that, so many, they have to invest on this to be able to get some rewards or so from that. Okay, Matangi. This money, I just want to say to people, please don't get scared. It's a more rigorous inspection, but again, it's for the betterment. So, yeah. Exactly. Okay, Matangi, so thank you very much. And I thank you for all those information, those details. I ask people to go to the show, they will find all the information again about the episode and contact Matangi also. And I wish you a nice day and hoping, because it's early for you, I think you are in California, it's really early for you. Hope people, yeah, if she answers a bit late, if you are not in Europe, so it's because yeah, she has been in California also. So, thanks again for participating, please put that. Thank you, and thanks for having me. Thank you. Bye. When you're a relatively medical device expert specialized on quality and regulatory efforts, my mission is to help you learn how to place a compliant medical device on the market.