Darrin Carlson, RAC-Devices, PMP on LinkedIn: 𝐆𝐫𝐞𝐚𝐭 𝐧𝐞𝐰𝐬! 𝐘𝐨𝐮𝐫 𝐐𝐌𝐒 𝐢𝐬 𝐧𝐨𝐰… (2024)

"Smallpox was always present, filling the churchyards with corpses, tormenting with constant fears all whom it had stricken, leaving on those whose lives it spared the hideous traces of its power."-T.B. MacaulaySmallpox is one of history's deadliest diseases. It's estimated around 300 million people died from it since 1900.And we can thank one specific medical device that we no longer have to live in fear of this illness.On the list of medical devices that saved the most lives, the bifurcated needle is near the top.This simple device does two things:1. Holds smallpox dose via capillary action2. Punctures human skin enough to administer itThe vaccine is highly effective, and minimal training is required. Because of this, it's thought to have saved around 130 million lives.Devices like this have helped people live better and longer, which is what drives me to be a part of this field every day!---Did you find this post insightful?♻️ Reshare to your network✅ Follow Darrin Carlson📧 Subscribe to my QMS Insider Newsletter: https://qarasolutions.com/

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The pressure of working in pharma QC was enough to drive me away from medtech for five years.The methods were often written in a confusing way, making them hard to understand.The acceptance criteria could be frustratingly subjective (melting points, I'm looking at you).Worst of all, other QC analysts would come and go, with people whispering about how so-and-so accidentally falsified data and got shown the door.It felt like I was just one human error away from getting fired.So I quit. Spent a half a decade in the wild west, working as an analytical chemist supporting biofuels R&D. It was a breath of fresh air in the sun-drenched paradise of San Diego.For a little while.That career stalled despite all my attempts to push it forward. So my wife and I put everything in storage and traveled the world for a few months.After that, we moved back to Minneapolis to be closer to family, and I decided to get back into medtech. I started working QA at a combination product manufacturer.While I love alternative energy, I feel like I can make a bigger difference in the world through medtech now.And the stress of making mistakes?It's mostly gone.Now I understand that human error is a part of any quality management system, and the issues I faced before were more about the systems than the people.While safety requirements in the medtech industry can make things stressful, the exciting technology and chance to make a difference make it all worthwhile.---Can you relate with this experience?👇 Share your story below.📧 Subscribe to my QMS Insider Newsletter: QARAsolutions.com

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𝐂𝐨𝐧𝐭𝐚𝐦𝐢𝐧𝐚𝐭𝐢𝐨𝐧 𝐂𝐨𝐧𝐭𝐫𝐨𝐥: 𝐀 𝐂𝐚𝐬𝐞 𝐒𝐭𝐮𝐝𝐲One common source of FDA inspection observations is inadequately established environmental controls.🔎 Let's look at a warning letter to Edge Biologicals Inc. from 2023 for an example.🔬 In this case, culture media used for environmental monitoring was not being monitored as required in their procedure. What's worse, this was a repeat observation that was also cited during their 2018 inspection!When the work environment can have an adverse effect on product quality, procedures to monitor and control the work environment need to not only be documented (as they were in this case), but also implemented (as they were not)!There's a lot to this requirement, so you will want to refer to the ISO 14644 series for cleanrooms and ISO 14698 series for biocontamination control.---Did you find this helpful?♻️ Reshare to your network✅ Follow Darrin Carlson📧 Subscribe to my QMS Insider Newsletter: QARAsolutions.com

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𝐌𝐃𝐂𝐆 2022-4 𝐑𝐞𝐯. 2, 𝐚𝐧𝐝 𝐡𝐨𝐰 𝐢𝐭 𝐚𝐟𝐟𝐞𝐜𝐭𝐬 𝐲𝐨𝐮......(probably not a lot.)MDCG 2022-4 (full title: "Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD" and are you still reading all this?) was just revised, just in time to coincide with MDR's birthday on May 26.While this document primarily applies to notified bodies, it can be useful for economic operators trying to understand their NB's process.As such, it doesn't introduce new information so much as it removes conflicting information resulting from the previous revision. It might be a good time to remind yourself of the new requirements in EU 2023/607 and how they affect the Article 120 Transitional Provisions, but this revision doesn't introduce anything you should lose sleep over.---Did you find this helpful?♻️ Reshare to your network✅ Follow Darrin Carlson to keep up with MDCG Guidance Document releases📧 Subscribe to my QMS Insider Newsletter 👉 QARAsolutions.com

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How do you know if your top management is truly committed to the QMS? 🤔There are some clues, if you know how to find them.The evidence for top management's commitment as defined in ISO 13485 also have their own sections in the standard:📢 Communication📝 Quality policy🎯 Quality objectives📊 Management reviews💼 Provision of resourcesSo if the organization does not adequately communicate the importance of meeting customer as well as applicable regulatory requirements, is that an issue with the Communication or Management Responsibility sub-systems?Here's my take. 👉If one of the factors is inadequate, the issue is with that specific sub-system. But the more sub-systems that have issues, the more likely the issue is with Management Responsibility itself.###Enjoy this post?📧 Sign up for my free QMS Insider newsletter: qarasolutions.com

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You could be a medical device manufacturer and not even know it! 😲(The definition is broader and more complicated than you might think.)FDA establishes different categories for manufacturers:🏭 Domestic Finished Device Manufacturers 🤝 Contract Manufacturers ♨️ Contract Sterilizers 📝 Specification Developers 🚚 Initial Importers / Distributors 📋 Complaint File Establishments 🔧 Remanufacturers 📦 Repackagers / Relabelers 🔄 Reprocessors of Single-Use Devices 🌍 Foreign Manufacturers 🏭 Export-Only Manufacturers 🏷️ Foreign Private Label DistributorsJust like other markets, the United States requires manufacturers to register their facilities (ref. 21 CFR 807) as one of the elements of conformity assessments. So don't forget to if your organization is on this list! 📝###Enjoy this post?📧 Sign up for my free QMS Insider newsletter! qarasolutions.com

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What is the 𝘳𝘦𝘢𝘭 impact of the QMSR on your QMS? 🤔Are you just assuming "no impact" if you are ISO 13485 certified? Worried you might be missing something? 😬ISO 13485:2016 contains no fewer than 33 references to "applicable regulatory requirements," which the QMSR will be starting on Feb 2, 2026. ⏳𝘞𝘪𝘭𝘭 𝘺𝘰𝘶 𝘣𝘦 𝘳𝘦𝘢𝘥𝘺 𝘰𝘯 𝘵𝘩𝘢𝘵 𝘥𝘢𝘵𝘦? 💼I've put together a free gap assessment tool that all medical device manufacturers can use to: ✅ Quickly identify all key differences between the QSR and QMSR. 📊 Easily assess impact on your QMS and any necessary actions. 🛠️ Create a quality plan to present to FDA investigators and MDSAP auditors. Just visit the following link, drop me your email, and I'll send this tool right over to you! 📩https://lnkd.in/gG4296fG

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𝐀𝐫𝐞 𝐲𝐨𝐮𝐫 𝐬𝐮𝐩𝐩𝐥𝐢𝐞𝐫 𝐟𝐢𝐥𝐞𝐬 𝐚𝐮𝐝𝐢𝐭-𝐫𝐞𝐚𝐝𝐲? 📂✅While you need to maintain 𝘢𝘭𝘭 your supplier files, it pays to pay a 𝘭𝘪𝘵𝘵𝘭𝘦 more attention to those that are more likely to be looked at during an audit or inspection. 💼In order, these criteria are:➡️ Suppliers with issues noted in recent CAPAs, NCMRs, and complaints ❌➡️ Higher-risk suppliers 🚨➡️ Suppliers of products or services that impact the design outputs ️📐➡️ Suppliers of processes that require validation (e.g., sterilization) 🔬➡️ Suppliers added since the last audit 📝➡️ Suppliers of products or services used in the manufacturing of multiple products 🛠️➡️ Suppliers not covered during previous audits 🚫(Bonus: you can use this same list if you are performing an internal audit to ensure you are selecting the most relevant supplier files.) 🔍---Did you find this post helpful?♻️ Repost to your network.And follow me for more.

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🔧 𝐀𝐫𝐞 𝐲𝐨𝐮 𝐬𝐞𝐫𝐯𝐢𝐜𝐢𝐧𝐠 𝐚 𝐝𝐞𝐯𝐢𝐜𝐞, 𝐨𝐫 𝐫𝐞𝐦𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐢𝐧𝐠 𝐢𝐭? 🔄Last week FDA dropped the long-anticipated Remanufacturing of Medical Devices final guidance document, which clarifies the difference between servicing and remanufacturing. 💡This could have a big impact for some that don't know the difference, since remanufacturers are required to have a quality system unless their device is GMP exempt. 📑FDA says a majority of the adverse event reports they receive that referred to inadequate servicing were actually related to remanufacturing. ⚠️So, let's start with FDA's definitions:➡️"Remanufacturing is the processing, conditioning, renovating, repackaging, restoring, or any other act done to a finished device that 𝐬𝐢𝐠𝐧𝐢𝐟𝐢𝐜𝐚𝐧𝐭𝐥𝐲 𝐜𝐡𝐚𝐧𝐠𝐞𝐬 𝐭𝐡𝐞 𝐟𝐢𝐧𝐢𝐬𝐡𝐞𝐝 𝐝𝐞𝐯𝐢𝐜𝐞’𝐬 𝐩𝐞𝐫𝐟𝐨𝐫𝐦𝐚𝐧𝐜𝐞 𝐨𝐫 𝐬𝐚𝐟𝐞𝐭𝐲 𝐬𝐩𝐞𝐜𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬, 𝐨𝐫 𝐢𝐧𝐭𝐞𝐧𝐝𝐞𝐝 𝐮𝐬𝐞." 🛠️➡️"Servicing is the repair and/or preventive or routine maintenance of one or more parts in a finished device, after distribution, for purposes of returning it to the safety and performance specifications established by the OEM and to meet its original intended use." 🔩So "servicing" is mowing your lawn, whereas "remanufacturing" is replacing the grass in your yard with clover. 🌱(And key takeaway: FDA mentions that many software changes likely qualify as remanufacturing due to impact on key characteristics.) 💻The document includes six guiding principles, as well as a helpful flowchart to help determine if an activity may be considered manufacturing. 📋Reshare if you found this helpful! ♻️

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