Practical Approach to Implementing LEAN Strategies for QMS Optimization

Hello and welcome everyone to today's webinar. which is practical approach to implementing lean Qms optimization. With medject leading voice and agra team and 4 special guests which we'll introduce momentarily while everybody's joining the call. I'd like to make a few housekeeping announcements which I'm going to cut and paste into the chat as well. So paste to everyone be. The housekeeping announcements are the recording and slides will be made available tomorrow. You should get an email with links to both. A special note about downloading the slides. Make sure you hover over the download button which is over the title on the upper left hand side. There'll be a note about that as well. It's just a little bit hard to find, but you can do it. I have faith in you next. Use the Q. And a button for your questions. Feel free to submit questions throughout the discussion.

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Thanks, so much

You know.

Thanks so much. Shawn. Yeah. Great to meet everyone today. My name is Dr. Andrew Gibson. I'm a senior managing consultant at Acro team. We are a full service consultancy specializing in in clinical, regulatory and quality needs in in Europe and other global markets. Yeah, a bit about myself. I'm I've been with Acro team since we founded in 2021, and consulting before that, working with different manufacturers from Ireland, from to Canada, and now in Germany. But yeah, hailing from Canada originally so great to meet everyone today, we'll just introduce the rest of our speakers. I have next on our screen. Malcolm Appleight

Thanks, Andrew. My name is Malcolm. Yeah. Been with Glyco for a number of years now, and also consulted in the medical devices. Space. I'm interestingly, I guess, from South Africa, which is not normal, I guess, for panelists on A, on a presentation like this, specifically based in Cape Town, and I can brag a little bit and say that Cape Town was voted the number one best city in the world for 2025. So you guys should definitely come visit. It's a fantastic spot. But yeah, happy to be part of the panel today and chat and all that up

Thank you, Malcolm and Jen Dixon. We have next

Hi, everyone. I'm Jen. I lead quality and regulatory at Ketrix and our client operations team. I actually previously worked with Andrew Amnesian neurotechnology. My background is in software medical devices as well as all the different jurisdictions in Mdsap. And I'm very excited to talk to you about lean Qms. Today

Thanks, Jen, and lastly, we have Hakeem

Again. Thank you. Again. Certification body. I am auditor, and this app and see Mark, editor. And since 5 year I manage the training center train, sometimes a bit, and my background is a biomedical engineer

Thanks. Akeem. great, let's get right into it here. So yeah, as you can see, our our topic today is lean strategies for Qms optimization. And before we get started, just a quick disclaimer that this presentation is intended for educational purposes. So we always recommend you to refer to the legal legislation standards and guidance documents for the most current information, and to ensure compliance this presentation, and of the other panelists is our opinion as and interpretation as subject matter experts. For at this present time, and basically that we, we're not liable for any different opinions from competent authorities, notified bodies or conformity assessment bodies.

So in today's agenda, I'll give a a background on our topic today. So where where are the Qms requirements coming from and how how to to set a bit of a background for our lean strategies. And and what kind of problems we're looking to solve, and what sort of symptoms you may face as manufacturers that may indicate to you that you have a a optimization issue with your your Qms. Or maybe you've already realized that. And and looking for answers. Then we'll be moving into a quick poll. followed by our panel discussion of various questions, and then a question and answer period from from the audience.

So yeah, it's it's important to consider, I think, who who should implement a quality management system. Why is it necessary to implement a quality management system and and what should be covered in our context of our discussion today. It's a. you know, medical device topic. I think manufacturers are obviously a a someone who would need to implement a quality system of both medical devices and in vitro diagnostic devices, but also economic operators, such as suppliers and and people who would be in your supply chain that you know. Specific economic operators would also undergo quality system requirements and and those requirements largely come from the European Medical device regulation, Emdr 2017, 7, 4, 5, and Ivdr 7, 4, 6.

But we know from other jurisdictions. Of course, there's quality management system requirements from global jurisdictions. And basically, they're all looking for overall consistent quality and and of of products and services and a customer focus. And from a high level. They mitigate business risks and ensure and consistent quality and and compliance and also from a business perspective, too, they're they're great to improve efficiency and productivity. When they're suited for your organization. And what do they cover? Well all processes and activities with impact on quality and regulatory compliance, including management and supporting processes. And they're applicable during all life cycles. So if you're a startup manufacturer, and of course you have a quality management system if you're a legacy manufacturer. But this is relevant for all stages of your life cycle, which we'll talk more about the life cycles in a slide or 2,

and we can't forget the Iso 13, 4, 8, 5 is the base for the quality management system requirements. And in Europe we're we're especially looking at the en Is013-45-2016, which is endorsed by the you know, Mdr. And Ivdr. And 13, 4, 8, 5 minimum requirements for Qms include these aspects so design and development, production, storage and distribution, installation, servicing and final decommission disposal of the device as well as provision of associated activities and the lifecycle as we discussed should be. Qms should be considered during all lifecycle steps. So we have from prototype to design and development and concept phase to launch and commercialization all the way through servicing end of life. And

yeah. So from start to finish, you should have your Qms. In mind, but I mean, if you're not in the market yet, you'll have different considerations than for a legacy manufacturer, or who are looking to discontinue certain devices. This is needs to be adapted for for the needs of the organization. In addition, in 13, 4, 8, 5, we have various chapters. So we have quality management system in chapter 4, providing an overall overarching principle to the other chapters of management resources in chapter 5 and 6 product realization that covers our design and development expectations in chapter 7 and measurement and analysis in chapter 8.

So in addition to what we've just seen from 1345 Umdr adds an additional level of level of complexity on top of that, through Article 10 for obligations of manufacturers, the Gsprs in annex one for general safety and performance requirements these are you know, help are showing compliance of your device, and that you have a safe and well performing product, and also from Annex 9 and 11, based on conformity assessment of the quality management system. So these are the considerations from Mdr. And these processes that we discussed have to be designed and implemented in such a way that we can demonstrate that the operation and control of the processes are effective.

that it has adequate transparency. We're ensuring availability of resources information that we're maintaining the effectiveness of those processes that we're monitoring measuring and analyzing these processes. You know, systematically ensuring and maintaining records of to demonstrate conformity. These these are considerations of those of those requirements. So I mentioned Article 10 obligations. So these are obligations to the manufacturer which believe most people on the call would be manufacturers. These are your obligations as a manufacturer from a quality management system point of view, and these are, in addition to what we see as a base 1345, requirement. So we have design and manufacturing requirements, risk management. Of course, we've seen a lot of

findings on risk management, clinical evaluation definitely, a topic that needs to be considered and processes involved with that technical documentation provides a lot more requirements over what we see. In 13, 4, 8, 5 requirements for custom made devices. Your EU declaration of conformity. Udi and udemed as well as document retention periods defined by Umdr as well as the control of changes, and 9 is the established document, documented, implemented, maintained, and continually improved quality management system. So we have to show show that that it's proportional to the risk classes of the devices in your portfolio.

And, lastly, we need to consider the post-market surveillance system in terms of Article 83 requirements, your your labeling and information to be that's provided by the manufacturer. Correction, corrective actions, withdrawals, recalls incident reporting access to information and device samples cooperation with competent authorities, information regarding outsourcing and compensation for damage caused by a defective device. These are all additional requirements from your article 10 obligations. So in summary, we can see like this is distilled version of the previous slide and kind of highlighting what you'd be expecting as the Umdr requirements. In addition on your quality system, the strategy for regulatory compliance is quite interesting and often looked at during a audit

and we can see from this. I think this is a good reference guide for for you on on the call that you can see here that 13, 4, 8, 5, and the crossover to umdr requirements largely. They're either partially or not covered by 1345. So it's a common misconception. We find that. you know, 1345 covers your Qms requirements from people outside of quality, because, of course, people who implement your quality system, if it's compliant, would be aware of this. But outside of quality. Yeah, there is additional requirements from Mdr for quality system. Now, this is where we start to creep into a situation where your process does not may not be optimized or lean anymore, because we have multiple requirements coming from different sources. And how they're implemented is key to make sure that they're, you know, flowing well and not adding, say, additional procedure, that you know that now you're checking 2 procedures or or having multiple requirements in different places.

and or just adding the verbatim text from Mdr. To cover the requirement. All of these would kind of be at risk of leading to, not to lean process. And we can look, start looking at what are the symptoms of a Qms. Needing optimization. So from our experiences, consultants and seeing deficiency letters from different notified bodies, we can see kind of different trends and situations that reflect and optimized Qms. and thinking about it, I realized, probably there's there's a bit of a difference between Smes so small medium enterprises and and large manufacturers. They have different growing pains or or different

kind of trends on the issues with Qms and with Smes. We're seeing experts really know the processes, but maybe they're not reflected so well in the procedures. And how you can see that is that during, say, an audit or internal audit or asking them you can see that they're following a process, but not the written process. And this can lead to lead to a situation that's you know that the procedures divert it is growing in such a way that it's no longer reflecting the procedure and is not lean, or is it, adding additional requirements that we don't know about. Additionally, there's a lot of questions that we get about purchasing kind of a.

it's a pre templated Qms. And and this might be appealing and and could be, you know, good in certain circumstances. But often, if you just implement templated Qms, this can lead to not being optimized for your your specific organization, which then you'd have a lot of additional requirements that don't apply to you, and really, your Qms. Should be tailored and should reflect your your processes. and not just a templated solution. And this I mean, these could all be related. But then you have implementation of unknown requirements where? You can't. Really, there's requirements in your procedure, but

nobody knows where they came from. They're not linked to regulatory requirements or or anything specifically. But since there's potential knowledge loss in in startups. Sometimes when someone develops the procedure, then they leave the company. Then there are 2 other people join. It's it's difficult to know exactly the evolution of the procedure. and how requirements came to be. We often see also requirements in several procedures that make it very difficult to follow the process so this can lead lead to issues. Unclear responsibilities is another common one. Where? It's not defined in the procedure exactly who's responsible or even the department? It's unclear. What department we're even talking about

because the names have changed. And that's where the outdated comes, and some sometimes we see specific names being called out in procedures, and this can also lead to dangerous situations. Also, the last one here is, I think, quite critical, is dependencies that are unclear. So I think now that we're entering kind of a more digitalized solution like Eqms and managing your technical documentation digitally, there's a lot more opportunities now to create better linkages between requirements, documents and processes. I mean requirements to requirements, requirements to risks. requirements to documents. It's all possible now, digitally, and this this is very difficult. If you're doing it by hand or by memory.

You might forget to update certain processes and and impact assess, change assessments, impact assessments or or can be done in a much more systematic and lean way now. and large manufacturers. I'll just cover really quickly here. So we have a lengthy, lengthy document approval. So if you're from a large global organization, I'm sure you can relate so this might indicate potential areas for improvement. Maybe there's and rel like people that aren't relevant for the sign off I'm not. We'd have. You'd have to look at the specific situation. But it might be an indicator of needing optimization over complicated procedures from cumulative feedback. So

I've worked to some legacy manufacturers who've been around for a really long time. and the procedures tend to kind of multiply and grow over time. and they just get more and more complicated, and it's easy to add and difficult to remove. So people add, add, add, and and never remove. So these procedures get really cumbersome and full of requirements, and it's important to also consider it from other perspective of removing and optimizing. What I call orphan documents or processes. So a couple of times we've come across situations where documents and procedures are actually lost within. The Qms. And are are kind of. You can tell that they've not been used for a long time, but still exist there. And yeah, this, this can

be also a sign of optimization required being needed multiple procedures. So we've covered this covering the same requirement and jurisdiction, specific procedures. So if you have vigilance procedures covering every single jurisdiction it might be worth considering how things can be optimized in that situation, so that you don't have so many procedures covering a similar requirement. And periodic review. If that's not being done effectively, then then the the procedures may not be reflecting the current process or reflecting current regulatory requirements for

yeah. Multiple situations can occur if procedures are not being effectively reviewed. So you might have a documented review. But is it being done effectively? So that kind of gives you a taste of where the requirements are coming from? Definitely from a European perspective but can be applied also globally and and some of the pain points that we see from manufacturers, and I think that gives a good background for our panel discussion. But 1st we'll do the the participant poll here. So I see that's launched on this screen. So you should be able to start going through the poll items here. And just while we're doing the poll.

We'll just be doing a quick question to our panelists. So, starting from the same order, we'll start with Malcolm. What is one thing you'd like to emphasize as being important to consider in designing and implementing a lean Qms.

Thanks, Andrew. I think something that's overlooked and can speak from experience, because I've done it is effectively mapping out your processes against each other, and where interrelation exists, because it's 1 thing taking different processes in their silos, considering who's responsible for certain things and how you might roll that out. But there's often a lot of interrelation between processes. and you can definitely streamline a process if you map it out properly. Consider who's involved and essentially come up with the most effective way to run the process. And I think by doing that you also

you you really get the buy in from your fellow colleagues because they can see the effort that's gone into it. They're involved in the process ideally and together you move forward with a well mapped out process, well documented, streamlined, and effectively lean. So that's that's 1 for me. Process mapping is very useful.

Good point. Yeah, thanks. And Jen, which one thing you'd like to emphasize. as being important when considering designing, implementing a lean Qms.

Yeah, for sure. I think sometimes we think of our Qms. Is just a bunch of documents which you know at the end of the day. That kind of is it? But it's really more of the people and the processes, and you executing it. I like to think of it as a living and breathing thing that you're going to change. So continuous improvement to me is the big 1. 1 of my favorite lenses is waste, so eliminating waste in the process, maybe not today, but a couple of months from now. Take a look at it again. I was actually just working on something with a very large client where they had a change control procedure, where someone had to manually justify each and every bug.

and had to spend that time. And you wonder, you know, what would have? How much would you have saved over the course of the year if you had just said, Hey, like we're going to justify all these bugs at once instead of each individual one. So yeah, continuous improvement

Good point. Yeah, these savings can be huge in terms of time savings. And and so we can focus on more critical aspects like that are related to the business. So that's a great point. And hakeem what? What is one key point that that you'd like to highlight for designing and implementing a. A lean Qms.

Yes, for me, for me. Designing Qms. Should be adapted to the structure adapted to the size of the company. Because, if you take just copy past of the other Qms. To other company. Copy past, for between 2 company it's not adapted, and more of our finding is focus for the for the startup that we, when we see the the younger Qms. That we see that they don't know how they can use the procedure, the the template, the forms, and it's buzz that the fact that he copy past one of the Qms. Give give by the the consultant for examples. And this Qms. It's not adapted for the size of the company. This is the key point that I want to share with you.

I think that's a great point. I think definitely with small companies. Sometimes it's very, you know, appealing to take that road of. You know, it's easier, but you can definitely tell it when they do that. So it's it's very obvious to anyone reviewing or like to notify bodies when when the copy and pasting happens, and it doesn't reflect their process. It's very, very clear. Thanks. So, moving on, I can see the poll is closed. Now. I think so. Move to the next portion of the which is the panel discussion. and we've put together some questions that that have come together regarding the the lean Qms. And you know, let's get right into it here.

So yeah, we'll start with Jen. What do you consider to be kind of key principles of a lean Qms. Like what? What do you see? As the lean principles and and what should manufacturers consider

Yeah. So I think, obviously, you know, changing it very often, there's a whole body of knowledge out there about how to apply lean methodologies. It all comes from the same world as software development, you know, agile methodologies. So you know, definitely, look at where the waste is going. Think about how you can sort of foolproof things so that you can never stray out of compliance. So pulling up those guardrails if you're already in a system that's already been validated, and you literally cannot take a noncompliant action. You're lean by design, right? Because there's almost no nonconformance, and of course that goes hand in hand with a risk-based approach which should be fundamental to a lean Qms. You don't want to boil the ocean. You want to have a risk-based approach for your product and your company.

Also, a culture of quality should be one of those pillars. A lot of problems go away when you hire really competent personnel who really prioritize quality. Oftentimes, you see process bloat, because we have to introduce another step for someone who prioritizes specifically quality in a particular process. And why not have that all be the same person who cares about quality and cares about your end user, which you know, for most of us is a patient. and I think, lastly, talking to, I think one thing Malcolm brought up is maintaining a traceability matrix of some kind between your regulatory requirements and the procedures you have means that in the future you can lean up certain areas as the company evolves and changes, and you don't have that apprehension when you're removing things, because you know exactly where these clauses came from.

Great points. all important for manufacturers to consider, and I came from your point of view, what are the common pitfalls that you see from manufacturers. Sure. Yeah, for for Qms. Pitfalls

Yes, the the common pitfall we find during our audit is, first, st more bad copy passed between different procedure and different templates, and the other one, that is, on the more procedure the manufacturer put the reference of the standard and the reference of the regulations, and for all the procedure they put this this reference. And sometimes we find that when a standard update, they forget to update this procedure. And we put and observations or finding sometimes. And for me it's not necessary to to write the reference of the standard or the regulations on all the procedure. It's very not usual, not not necessary, other issue, we find that this is the regarding the management of the right persons. Times. They don't take the.

the, the dispositions to to take the record, and during the times that the regulations require some and other things. During the transitions, the link between the different process and different procedure, like between Kappa and management risk between payments and management review, between change, control and risk management, and so on the link between different process. It's not easy for the for some manufacturer. This is that I want to share with you that interlinking is key and kind of the

Next level what you see. And and it's really like, you see that a lot with Mdsap audits and and the linkages that are noted between the various processes, and and, I think, for manufacturers with Mdsap. It's usually kind of ingrained all the linkages from the the audits. But just your mention about the referencing the standards. I I think I see that a lot, and and I also see kind of hard hyperlinks to various kind of external, you know, websites. And how do you feel about kind of the hyperlinking? You know, to web addresses in procedures? I I'm usually advising against it because web addresses change, and you know they. But what is your feeling on that

I think that's they. They need to put the the link in only on on on one document. And this document. It's a you. You update only one document, that if we take the the example of the the Sanders, we write all the regulations in one files, and we say that I refer to this document

Right? Yeah, okay, yeah, that's makes sense. And and we have another question for Jen here, what what processes do you think are are best suited for lean principles are, are there kind of more kind of low hanging fruit processes that would be best adapted for kind of a lean process, or where where manufacturers should start with their lean initiatives

Yeah, I mean, that's a really big question. I think if we think about how we're doing as a species in the past quarter century. We've done really well at leaning up production processes. So physically, making things. We're really good at that these days, and I think Lean has gone a long way in doing that. So if you haven't done that yet in your production process, and you're in a scaling environment, definitely. Take a look at that 1st you'll see a lot of savings there. But certainly, if you're an early stage startup, if you only have a couple of builds that you're making, you'll want to take a look at design and development, because there are so many different ways. You can fulfill the requirements for design and development for all the different jurisdictions, and you have a lot to play with there in justifying how you want to do your design reviews all the different phases. So I would definitely take a look at that, because that should really be something that is tailored to your team and your technology.

And of course, I'm always a big fan. Shift your approvals to the left. Try to get things approved as early as possible, so that you're not waiting till the end, and you keep it as lean as possible.

Makes sense. So that's a good recommendation. Where to start. I think we all have our that's depending on where what function? You're a part of so probably, everyone thinks their own department. But yeah, it's it's it's worth looking at. I I don't know during either looking from external internal, like another department to maybe get a second per perspective, because a lot of people working in the the Department, I think, wouldn't have a fresh pair of eyes. You can always reach out to good consultants and but even internally might be a good place to start for looking to clean the initiatives. next one, we have a question from Malcolm, how how have you seen that digitalization? Can be used to optimize the Qms. So, yeah, what either

digital programs or or what have you? What have you seen? is kind of best implementation implementation of digitization for your Qms

Yeah, I think I think, just to speak to this point in general. digitalization. If you're taking on a tool that's being built and prepared, and you're paying for on a monthly basis or you're spending some time digitizing a particular workflow. I think the point is that it's standardized right so, and especially one of those Eqms platforms where they've taken best practice. They've got great people in the room built out the system to follow a particular process. It's for the most part going to be lean. I think, Jane, you said something earlier about putting those guardrails in place, and if there's enough of those guardrails.

you will be compliant and more importantly, quality works for the business you'll you'll be lean. So to take those. Take those systems. There's a lot of value in it, because you automatically, if it's 1 of these Eqms platforms that we can rattle off, you automatically, become compliant to use it properly as intended, and you also will find that your process becomes a lot more lean. There are obviously other digitization options where you you take digital tools out there that you can then apply to the workflow that you you put together. So if you prepare to do that, spend a little bit of time on digitizing. You know your methodology.

You'll essentially put down those guardrails and help yourself out. but it will take a little bit more time and a little bit more of internal management. So there's different different things to think about. I think when you thinking about digitization. you know, are you gonna go with something that you put together yourself. With particular tools, or go with an e-commerce platform. There's a cost considerations. There's validation considerations in particular. So if you're doing it yourself. Please keep in mind that software validation is something you need to do as a manufacturer. If you're making using software to to make decisions in your Qms.

You have to consider the validation part as well. Which which do you have the skills in house for that or not? That's another question. So digitization, I think in general will work to you to your favor. But how you implement it? what tools you use to implement? It is definitely worth considering.

Thanks, Malcolm, and I think I mean. when I'm thinking of these solutions, I I always am worried about the you know the initial phase of switching over, and that the headaches of switch switching from whatever either paper based, or another kind of you know, sharepoint or or some other switching. Qms. Seems to be a big, daunting task. Do you have any kind of like less kind of thoughts about that switch over, or it like it must be worth it in the end. But getting over that initial hurdles can be huge

Yeah. The the initial hurdle is is a big challenge. I I think you can. Also, it goes without saying, in the quality world. Plan your your pathway forward. and and I think, tackle, tackle what you can, based on your company size. Get some good advice and and migrate in a way that make sense for you as a company. I I can speak from experience at at Glyco. We've made the the transition from a very heavy paper based system. Into a full Eqms solution. And the one thing that we excluded in the initial move is the was the the Mdr. Technical documentation that we were working on. We're legacy company legacy product. We built out the technical documentation old school way, but we rolled out the rest of the Qms. On the on the platform

and got that going. And we we've taken a as an example, and this is not a 1. Size fits all solution. But as an example, we've we've taken the position that we will wait for notified party feedback. We will respond to that feedback update documentation, the old school way. And then once we've got something ready to go. We've got a C mark. We'll then start taking all that technical documentation and feeding it into the Eqms, creating those links from requirements to outputs and then in the future monitoring it and then managing it through the Eqs platform. So, you know. don't throw the kitchen, sink at at your at your Qms. With digitization, but but certainly work towards that where you can increase efficiency. So I mean, at like our. For one, the Qms. Is far more efficient than it's ever been.

and the technical documentation will get there too.

I think that I think that's good advice. So it's it might be. You know. you might want to rush into it and get it all. Everything switched over as fast as possible, but it should be planned and and done very methodically. Otherwise you'll you'll run into huge problems. And yeah, issues with the the transition, yeah, thanks. Great. Next point we have for hakeem. so on the other side of Qms digitization, have you seen situations where it can also implemented. Maybe the wrong way would lead to over over complication

Yes, we we can. I can show you 2 2 examples for for the kind of the complications. The 1st one is the time to implement the the digitalizations of the Qms. Is very long for the company. And so the 1st step is to to write the to digitalize the process for for the review, for the designs, or for all this, the stage, and we begin the we go one year to to audit the the customer for the manufacturer, and he said, We have a project, and one year after the project is not finished, and we can see that he he he finished only half of the process and the Times to to implement it very long for the manufacturer. The second.

the second complications. I I see that you know that for the stage. Once certifications, all the certifications body. Ask the the copy of the procedure to review before the stage. 2. Because the initial audit is stage one and stage 2, and to share the procedure with the notify body or with the certification body. It's not easy if we don't if we don't upload. Sorry the procedure in the in the in the paper, and it's not easy. Our other ones is if we if the digital is everything. So we maybe the the discussions discussions between the the guys. It's not. It's it's it's not here. During the meetings everybody take the the laptop and said, Okay, I valid. I approve. And I saw no discussions between the the different guys during the review of the document, or during the design review or management review, or all the the records need to be reviewed by more of one person

Excellent great point which I I've seen, too, a lot of people don't understand or or review effectively. Yeah, and then still, the review process can take a long time, even though they're not reviewing it effectively. Yeah. interesting situations. Thanks for those insights. the next question we have is for Jen. What are the best practices? Do you think for startups that you've seen developing a Qms. Or Eqms.

Oh, well, actually, going back to what Malcolm was saying, it's tough to transition from paper based to digital. So I definitely recommend, if you can do it. Try to go straight to digital unless you're 100% sure, you're going to get acquired before you leave the research phase. I think, timing your internal audit getting someone who can do that for you is pretty key. You want to do it right when the team is utilizing their your Qms. And then you'll get that little check, that little verification that you're doing it the right way, and you feel a lot more prepared going into that notified body audit.

And then, I think, as you were saying earlier, Andrew, the steps of justifying whether processes are applicable or not, or right sized. You have to tailor your Qms. For your startup, whatever you're building, even if you're not sure what you have yet, you know is, change it down the line. You want to make sure that's tailored so that you're not doing excessive practices that are just not applicable for your technology.

Right. And I think I I mentioned one pain point of of startups earlier is like kind of knowledge loss. And you know the initial founders that are, you know, so into the processes and design and development that when they leave there's like this huge hole. Do. Do you have any suggestions or or thoughts on how to kind of mitigate those risks of knowledge loss when when those key people leave. I know there's always kind of situations where you, you try to do effective knowledge transfer. But I mean, sometimes that doesn't occur is not happening effectively. And it's impossible to, you know, copy someone's knowledge, and you know, paste it somewhere else. So I mean, there's always some loss. What do you? What do you think about that situation?

I think when you're dealing with individuals and startups who may not have worked in medicalized before, try to get them to write it down, even if you know it's not going to end up with the Qms. But it's something you can refer to in the future. You'll never know if you need to maybe create like a design review record to capture some of that information, or you can find someone else who can kind of interpret some of it. So I definitely say, just try to get them to write it down, even if it's just meeting notes like on this day. We discussed this thing. And he told me about this thing, or she told you about this thing. Yeah, that'd be my main recommendation.

Yeah, and organize those? Well, absolutely. Yeah. Okay. And next, another question for hakeem, can, what do you suggest about kind of managing periodically updated documents in the Qms. Can can they be managed within the Qms. Or what suggestions do you have about managing those periodic updates like, what we're talking about is something like a clinical evaluation. Psur updates. And yeah, any any regular updated document? Sscp, these sort of documents that we're seeing under? Mdr

You speak about if you speak about only regarding the record that the Mdr. Request, like you said that the the pure or the clinical evaluation. Sure, with the Qms the with the sorry, with the Qms digital is. It's easy because this these tools send send send send an email or something information that it is a times to update. And it's may may be easy to to to to take all the informations to update this. But if you, if you go to the modify, the procedure, modify the Qms. Not the record. I speak about the the provisions, not the record regarding the provisions. If you update

periodically. So so sorry for my, so sorry for for this, it's not easy for me, because the the time that you update in the Qms. And the Times to to to the guys need to be trained. What is the times to to implement the procedure? In the some manufacturer. They put that I update my procedure on Mondays, and the implementations will be begins in Fridays, because you have times between the updated procedure and the implementations, and it is one of the of the of the challenge the company should should take for for the records. It's good, but for the provisions. It is one other challenge, you know.

Yeah, I mean, there's so many. I mean, there's the records that I think people have a good idea, and, you know, have various ways of tracking. But the actual procedures. Yeah, we're seeing from our side. We're seeing lots of manufacturers like create like they have to be reviewed at some frequency, and then maybe they have some sort of way to remind them that these procedures have to be reviewed by. If they have a specialized job control department. Then they can, you know, flag them for reviews based on some frequency. But but that's an interesting point about the implement. So what you're seeing and maybe is effective for some manufacturers is like you have an approved process. But then have this a bit of a delay or a grace period until the actual implement.

when it comes into effect

Hey? So then, for training, for example. just 1 point I would like to share with with you that. So in the previous standard. Let's say right that we need to review provisions every one year. So every 2 years. But this this requirement, it's not in the new revision of the iso and more of the manufacturer. Take this, that's every every year. So every 2 years, for example. they're right that I need to review my design procedure, for example, or the control procedure. It's not a requirement, it's not a requirement for the certifications, body or notify body or regulations. It's the Qms manufacturer requirement and more times. They don't respect these these timelines.

and it's very important that they know they are. It's very important that the manufacturer know the standard, know the the requirements and implement just implement for me

Right. And if you see what if you see a note of a manufacturer who's gone above the, you know the standard expectations. and they have proceduralized and say they'll review it every one or 2 years. If they're deviating from their process, it can still be, you know, an issue. Right? Yeah.

Yeah, yes. I put an issue right? Because the issue

Did not leave.

In the provision network. I didn't understand that. Yeah, sure

So this is great example of of things to watch out for Andrew. If I if I'm if I may

Something else. I think that's worth noting on the regulatory documentation that requires periodic updates. We mentioned the Cr risk management documentation. Psur, Pmcf. etc, and I think that it's it's worth noting that. You know. One of the the 1st question answered. I spoke about process mapping. and I think if you took those processes and you map them together, you would notice quite quickly that there's that Matryoshka dole effect that Russian dole effect where you've got this plan inside a plan that results in a report inside a report. And it's very important for startups. And I think younger companies, smaller companies to to realize that there's certain documents that they need to have in place, that they could write another documents, and they develop a report so they can write another report.

and all of those interrelations take. It takes time to to do that once you've set the plans in place, I guess next year, if there aren't many changes. You don't have to worry about updating the plans necessarily especially say your Cep. But the the cr, the literature review, those take time. And if you're a small company with limited resources, you know, you might need a couple of months for each one of those documents, and then you need to consider your quality management system cycle. When are you going to get audited again? Do you have the latest revision of that document ready? So it's definitely something for the smaller companies to consider.

that how these regulatory documents interrelate with each other along with all your other quality management system, documentation requirements is worth is worth noting and and scheduling that correctly, with the resources that you have, so that you can be compliant and provide your documentation correctly to your notified

Yeah, sure, sure. But but update the regulatory records. Update the regulatory documents required by the regulations. It's not the same that you update the management review procedure for examples. You know, I I just focus that. It's not the same things that I am agree with you that if the small company or big company write the quality plans. That's every 2 years they update the every year. Update the technical documentations. It's a good point, because they respect the regulations. But if they write that, update the design procedure, update the management review procedure for me, it's not necessary, and I don't put an issue. But if they don't respect their provisions, I can put an issue

Right? So the manufacturers in that case are setting a higher expectation for themselves. On their own. So they're yeah. That's that's great point. And to Malcolm's point. Yeah, I think there's a lot of efficiencies based on the planning of the scheduling. Like, you need your post market data to be incorporated in the Cer. So plan your Psur your post market data collection, considering your clinical evaluation frequency. So all the inputs. And there's a huge or interdependencies that need to be considered. And I wanted to ask one more question before you switch to the QA. Maybe just quickly with Jenna. Do you have any ideas about?

What role kind of AI or what you've seen? AI to be as a player in in lean Qms.

Yeah, I've seen a lot of AI in the past couple of months, and I'm actually very excited about it all. I think one of the top ones is definitely the ability for AI to as an information technology provide early alerts for when things might be heading towards a Kappa, or you might have an Ncr in your hands. AI can monitor everything all at once, in a way us humans can't. And what I love is that they can basically be your early warning. Qa. Coordinator, who can let you know where a potential problem might be. You can schedule your AI agents on A, you know every Friday. Look at all the new anomalies that have been raised. Is this more than what we typically see this time, this time of year, that sort of thing

today. Obviously, people are using AI for note taking, which is fabulous makes those design reviews really good. If you have it integrated into your Eqs. That's even better, and actually touching on what Malcolm raised around, how all these documents are kind of repackaged versions of each other, or they're dependent on a plan and to make a report. What's brilliant about AI is that it can understand all the dependencies between these documents. It knows the mapping so it can help even a new hire, or someone who doesn't understand all the mapping it can suggest where those people need to start 1st in writing those documents like, Hey, don't get started on this document. You should prioritize this 1 first, st because we know that that one's not ready.

So I say, I'm very excited to see how AI can play a role in leaning up your Qms. Because it has access to all the data and can tell you where to focus

Yeah. good. Good point. And yeah, I think there's no stopping it in a certain way. And the people adopt, it will see benefits. So yeah, it'll just be part of our our world at a certain point, and just need to stay ahead of that great. So I think we're in our Q. And A. Sean, will you? Will you do the questions or

Sure I'd be happy to so this one came in over the chat. Any recommendations to have a good control of external documents from suppliers, external documents from suppliers in Qms.

So let's see. The question was how to control external documents or external processes or documents from suppliers

This is any recommendations to have good control of external documents from suppliers. So I guess it's external suppliers

Okay. I think that's usually through kind of supplier evaluation and and external audits that that's usually handled. I know there's you can write up mandates and agreements. If you take on certain responsibilities on behalf of your supplier like, if you are if they're falling under your quality management system is another kind of more complicated way. If you feel that they don't have an implemented quality system, they could potentially fall under yours, but needs a lot of thought and considerations, but it is an option given the the correct circumstances. But usually I would say that without knowing more about the question that it'd be through the supplier evaluation process and and auditing, based on the the risk of that. If they're a critical or non-critical supplier any other

comments from the team course, from the from the panelists

Yes, so so just just one comment. You. You just speak about the contract between you and the subcontractor. It's the one way, but the contract should be specify. very, very specified. The the retention times, and which record the the subcontractor need to to record. This is one way, but a contract. It's not the final solutions, because the manufacturer should verify that the contract is respected during the audit. and if the the Me. On auditors, I will check that. How you verify that the contract is respected between you and your suppliers, and give me some example for traceability, for retention record, and so on. This is one way. The other way is that if the suppliers doesn't want to keep the record during

10 years after the last project put in the market, for example, they can keep the record in the manufacturer and scan the documentations, and he he manage also. Very good. The documentations for me and supplier. It's not only manufacturer supplier. You don't remember that supplier. There are some metrology, metrology. you know, for the measurement documents, and for the trainings, and for more things, not only for the supercontractor of the manufacturer, or designs

Thank you.

Thanks.

So this is an interesting question, should cybersecurity be part of the Qms. Given the medical device products involving software that present security risks

Think? Yes, yeah, you you should have procedures covering cyber security. And also, you know. records as well demonstrating the cyber security of your device. And and there's several you know, standards covering this and and also guidance documents depending on what jurisdiction we're talking about. But we have Mdcg documents covering cyber security. And I think short answer is, yes, it should be covered in your quality management system.

Good. What are the requirements and potential gaps? Major gaps, I would say, to address when transitioning from Iso, 13, 4, 85, 2016 certification to Mdsap. Gen. Empty shop question. So major gaps, what are the major differences that they need to look for? 1385 to empty sub, you know

You know. That's oh, sorry, sorry, Jen, 1st for the girls, for the woman. Sorry

I have a feeling you're going to see somewhat similar. So if you're on Mdsap, you're going to be using a lot of the practices in 1345, where you're going to see a lot of additional pieces are around. Obviously vigilance as well as sorry getting the change. Impact assessments done for each jurisdiction. Everyone has their own flavor of what that looks like as well as supplier management. You can when you go through the Mdsap approach. There's specific clauses for each jurisdiction that you should definitely take a look at Hakeem. I think you probably have some more clarification around that conversion. Go ahead.

Thank you, Jen. You know that for the manufacturer and this happened, I know it's not really different. The main difference is for the auditors, because the auditor need to respect the process and put some issue for the grad grad one until 5. But for the manufacturer, if he go to, if he put the the project in Japan in the Us. In Canada. usually he will respect the regulations of this country like he put a iso and had the specific specific requirements of the Canada of Japan, of the the 5 countries. Look for me for the manufacturer. It's the same

Thank you. So we're about out of time. There are a number of questions left. We'll try to follow up with the individuals with answers to their questions. I'd like to thank all of the panelists for your contributions today and your time, as well as everybody who took time out of their day to attend the certificates of attendance will be mailed out in the next few days. We do create them manually, so please be patient, and also be generous and share them on social media and call out what you liked about this event. You know it's an awesome thing to do. Linkedin is a great place to share your certificate and tell everybody

what you've done. So with that I'm going to allow the speakers to say goodbye. Fine

Thanks. Everyone.

Cheers. Guys thanks so much. You, too, cheers, guys.

Thank you.

Thank you.