Intrinsic Medical Group, LLC

Happy Monday! 1️⃣ The FDA has added an extra 30 days to the comment period for the draft guidance called "Chemical Analysis for Biocompatibility Assessment of Medical Devices," extending it to December 19th. The agency decided to do this because stakeholders asked for more time to respond. 2️⃣ FDA CDRH is having its next online town hall meeting about medical device sterilization. These meetings are meant to help the agency and stakeholders talk about using less ethylene oxide to sterilize medical devices, because the Environmental Protection Agency has made rules that limit the use of this gas. 📅 October 30th 🕐 1pm ET 3️⃣ FDA issued daft guidance on Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method. It states that Biocompatibility tests should include extractables and leachable studies and a toxicological risk assessment of these chemicals. 4️⃣ The Medical Device Coordination Group (MDCG) has updated its guidance on applying Medical Device Regulation (EU MDR) requirements to legacy devices. The document has been updated to match MDCG guidance formats and includes changes from Regulation (EU) 2023/607. Key updates are in sections 3.1, 3.2, and 4, clarifying rules on legacy devices, transition provisions for certain systems and packs, and requirements for a quality management system. 5️⃣ The Health and Youth Care Inspectorate (IGJ) checks on how medical device manufacturers in the Netherlands are keeping track of their products after they are sold. When the IGJ visited 13 manufacturers in 2023 and 2024, none of them met the required standards for monitoring their products (i.e. PMS). They are urging these manufacturers to set up an effective system for this purpose. 6️⃣ The Medicines and Healthcare Products Regulatory Agency (MHRA) says that the new proposed law will make the postmarket surveillance (PMS) requirements stricter and clearer. This is the first big change to the medical device regulations in Great Britain. 7️⃣ ISO 25539-3:2024 Cardiovascular implants — Endovascular devices Part 3: Vena cava filters has been updated *** I'm Marina Daineko and I talk about biocompatibility. If you are a fan of it too, like and share this post!

Did you know? Check the influence of processing medical devices from an ISO 10993-1 perspective. Interested? See the carousel! *** 🔔 Follow us and ring the bell at Intrinsic Medical Group, LLC ♻️ Repost this to share the biocompatibility insights!

Other Biological Effects in draft ISO 10993-1 You’ve already reviewed the specific biological effects. But, think about “other biological effects”. Check if they relate to your medical device. What are these “other effects”? (part a!) ✅ Neurotoxicity ✅ Immunotoxicity ✅ Reproductive and developmental toxicity Check the carousel for more details. *** Want more biocompatibility insights like this? Follow us and ring the bell at Intrinsic Medical Group, LLC ♻️ Share this to spread the word on ISO 10993-1 updates

GLP for Biological Evaluation GLP stands for Good Laboratory Practice. Using the same analogy with a company that makes cookies GLP would involve testing the cookies in a lab first to ensure they are safe to eat. No, you should not invite your favorite colleagues to try these cookies at this phase. Firstly, you should check in the lab whether they work as intended 😉 It means that GLP describes the controls under which non-clinical studies are planned / performed / monitored / recorded / reported / archived So, GLP would involve testing cookies to see if they contain toxic substances or cause allergies. So, where should you look? 💠 𝐅𝐚𝐜𝐢𝐥𝐢𝐭𝐲 𝐚𝐧𝐝 𝐄𝐪𝐮𝐢𝐩𝐦𝐞𝐧𝐭 When experimenting with new flavors, you want to ensure that each batch is prepared correctly without any cross-contamination or interference from other flavors. The lab should have separated zones: 🎾 Zone for the receipt of test and control articles 🎾 Zone for their storage 🎾 Zone for the housing of the test systems By the way, equipment should be periodically calibrated and maintained. The lab should keep records of calibration 😏 💠 𝐒𝐭𝐮𝐝𝐲 𝐏𝐫𝐨𝐭𝐨𝐜𝐨𝐥 𝐚𝐧𝐝 𝐑𝐞𝐩𝐨𝐫𝐭 You have a Biological Evaluation Plan where you describe the testing strategy. For instance, at Intrinsic Medical Group, LLC, we also indicate what type of test (not just cyto, but what kind of cyto), how many samples, and other considerations there. The Study Protocol contains very specific information on which exact cookie shall be tested, what equipment used, version of the standard, the general time schedule, and other details. The Study Report describes test results, any deviations, scientific interpretation of results, and a GLP Compliance Statement by the study director. Both documents should have an ID number, date, reviewer, and approver signatures. And we logically can jump to 💠 𝐏𝐞𝐫𝐬𝐨𝐧𝐧𝐞𝐥 𝐐𝐮𝐚𝐥𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬 The responsible person for the testing should know what they are doing, why, and how. There are two important roles: 🎾 Study Director, who is responsible for overseeing the entire testing process and ensuring compliance with GLP standards 🎾 Quality Assurance Unit: this independent team ensures that all aspects of the testing process are conducted correctly and impartially, maintaining the integrity of the testing procedures 💠 𝐒𝐭𝐨𝐫𝐚𝐠𝐞 𝐨𝐟 𝐑𝐞𝐜𝐨𝐫𝐝𝐬 You have got the study protocol and report. But it’s not the end. The lab should archive documents at the end of the study. There are specific requirements for the archival of such records. They relate to retrieval, audit trails, legal holds, accesses, and many others. If you are interested, let me know 😉 What did I miss? Feel free to comment! *** I'm Marina Daineko and I talk about biocompatibility. If you are a fan of it too, like and share this post!

What would the CAPA man recommend to Biocomp Engineer regarding their finding? Check the post from Georg Digel!

Biocompatibility is not a bubble! It's a lifestyle! We're launching an electrifying new series! Join us as we team up with Subject Matter Experts to unravel the steamy connections between 𝐁𝐢𝐨𝐥𝐨𝐠𝐢𝐜𝐚𝐥 𝐄𝐯𝐚𝐥𝐮𝐚𝐭𝐢𝐨𝐧 and 𝐨𝐭𝐡𝐞𝐫 𝐐𝐌𝐒 𝐩𝐫𝐨𝐜𝐞𝐬𝐬𝐞𝐬 within the company (and not only!) We'll spice things up with real-life examples, making it super easy for you to incorporate these hot tips into your daily grind! Expect the unexpected as we uncover some sizzling surprises along the way. Are you ready to turn up the heat? Let’s ignite this series... ...starting with CAPA! Introducing the charismatic Georg Digel, who will lead us through a tantalizingly common scenario our Biocomp Engineer encountered. P.S. This is just the appetizer. Don’t miss the main course - Georg Digel's post coming tomorrow! *** Want more biocompatibility insights like this? Follow us and ring the bell at Intrinsic Medical Group, LLC ♻️ Share this to spread the word on biosafety!

Happy Monday! 1️⃣ The FDA’s Center for Devices and Radiological Health (CDRH) announced it is launching the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot. TAP's main aim is to speed up patient access to new medical devices by having regular and strategic discussions with the FDA and helping device developers connect with other important groups, especially for devices that are crucial for public health. The TAP Pilot is now open for enrollment requests for Breakthrough Designated devices reviewed by: 💠 Division of Ophthalmic Devices 💠 Office of Cardiovascular Devices 💠 Office of Neurological and Physical Medicine Devices 💠 Office of Radiological Health 2️⃣ The FDA hold Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A Check the details available at Intrinsic Medical Group, LLC last post 3️⃣ Mark your calendar! I am excited to be a course leader for Medical Device School, and 𝐲𝐨𝐮'𝐫𝐞 𝐢𝐧𝐯𝐢𝐭𝐞𝐝. I will be speaking at two sessions: 🟣 Biocompatibility with Malene Nybo Othendal Nielsen from Convatec 🟣 Post Market Surveillance with Stephanie Berger from Philips Join us for an event where innovative technology meets regulatory requirements. You can participate in discussions and learn something new from Nov 5-7. 4️⃣ This week, Intrinsic Medical Group, LLC kicks off our exciting series, "𝐁𝐢𝐨𝐜𝐨𝐦𝐩𝐚𝐭𝐢𝐛𝐢𝐥𝐢𝐭𝐲 𝐢𝐬 𝐧𝐨𝐭 𝐚 𝐛𝐮𝐛𝐛𝐥𝐞." What do we mean by that? Biocompatibility is vital for ensuring the safety and effectiveness of medical devices in relation to human use. By weaving Biological Evaluation into a company's Quality Management System, we prove that Biocompatibility is a core, lasting element of medical device development, not just a passing fad. In this series, we'll dive into various processes and their ties to Biological Evaluation, underscoring its critical role in upholding safety and compliance. And we're starting with... drum roll, please... Georg Digel and a captivating use case involving CAPA. Stay tuned with Georg Digel and Intrinsic Medical Group, LLC - hit that follow button and ring the bell 🔔 so you don't miss out on our posts. And why not grab some popcorn while you're at it? 😉 *** I'm Marina Daineko and I talk about biocompatibility. If you are a fan of it too, like and share this post!

I’m happy to share that after passing the exam, I’ve obtained a new certification: "Biological Evaluator and ISO 10993-1: 2018 Subject Matter Expert" from Intrinsic Medical Group, LLC, following the really interesting biocompatibility workshop at the MedTech Conference 2024.

Did you know? Recently, the FDA held a town hall meeting about sterilization. This town hall was focused on the topic of medical device sterilization, specifically discussing Predetermined Change Control Plans (PCCPs) based on a draft guidance that was published in Aug 2024. The purpose of a PCCP is to identify the changes that a manufacturer intends to make to a device. This could include changes from one method to another, and the PCCP can be a valuable tool in this process. A PCCP is used as part of a marketing submission for medical devices, either within a 510(k), De Novo, or PMA. It is recommended to be included as a standalone section with a title and version number in the submission. If the eSTAR submission method is used, there is a mechanism to signify that the submission has a PCCP under the device description section, under the device attributes. The general content of a PCCP includes three key elements: ➡️ the description of modifications, ➡️ modification protocol, and ➡️ impact assessment. As for sterilization-related modifications that may be appropriate for a PCCP, the FDA generally believes that changes in sterilization, packaging, transport, or expiration dating may be appropriate when using well-established methods. For a PCCP modification and a PMA submission, it is generally believed that it would be limited to more minor changes in these areas. For instance, for a non-absorbable polyethylene surgical suture, a change to a different non-novel sterilization method could be appropriate for a PCCP. However, a change from a device labeled "for single use only" to a device labeled as reusable is generally not considered appropriate. In the case of PMA, changes that are appropriate for 30-day notices may be appropriate for inclusion in a PCCP. Examples include a change to the test site for sterilization test samples, where the specifications are unchanged, and a change to the aeration time used at a sterilization site. *** 🔔 Follow us and ring the bell at Intrinsic Medical Group, LLC ♻️ Repost this to share the biocompatibility insights!

What an exciting collaboration this is going to be! Stephanie Berger from Philips and I, with the support of Intrinsic Medical Group, LLC, will dive into the world of Post-Market Surveillance. As our PMS Magician, Stephanie will unveil the intricate details of PMS. I'll be sharing insights on how to creatively utilize PMS data (and requirements!) for Biological Evaluation. Also, I'll share some details about it from current draft of ISO 10993-1 about biocompatibility. Why not join us on November 7th? It's a Thursday at the Medical Device School organized by Informa Connect. I have a soft spot for Thursdays. They're practically a tease for Friday, aren't they? Let’s make that Thursday memorable together! Full agenda: 💠 What is Post-Market Surveillance (PMS)?  💠 PMS in the context of the overall regulatory framework  💠 Impact of EU MDR / IVDR on PMS  💠 Post market surveillance and Risk Management  💠 Trending of complaints and adverse events  💠 Investigating complaints  💠 Post market surveillance reports/ PSURs and feedback loops with CER and PMCF