Accreditation Standards Updates

On December 22, 2025, the 𝗙𝗗𝗔 updated its 𝗥𝗲𝗰𝗼𝗴𝗻𝗶𝘇𝗲𝗱 𝗖𝗼𝗻𝘀𝗲𝗻𝘀𝘂𝘀 𝗦𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 𝗗𝗮𝘁𝗮𝗯𝗮𝘀𝗲, adding 𝟭𝟬𝟬+ 𝗻𝗲𝘄 𝗼𝗿 𝗿𝗲𝘃𝗶𝘀𝗲𝗱 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀, with a subset eligible for use under the 𝗔𝗦𝗖𝗔 𝗣𝗿𝗼𝗴𝗿𝗮𝗺. For manufacturers working in the 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗲𝗹𝗲𝗰𝘁𝗿𝗶𝗰𝗮𝗹 𝗲𝗾𝘂𝗶𝗽𝗺𝗲𝗻𝘁 space, this update includes several 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭 and 𝗜𝗘𝗖 𝟴𝟬𝟲𝟬𝟭 standards that are directly relevant and 𝗔𝗦𝗖𝗔-𝗲𝗹𝗶𝗴𝗶𝗯𝗹𝗲. The update also highlights how ASCA applies across a broader range of 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲𝘀, including 𝗜𝗩𝗗𝘀, 𝗰𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝘀, and devices that are not based on medical electrical equipment. 𝗔𝗦𝗖𝗔 𝗲𝗹𝗶𝗴𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝗮𝗽𝗽𝗹𝗶𝗲𝘀 𝗶𝗻 𝗺𝘂𝗹𝘁𝗶𝗽𝗹𝗲 𝗮𝗿𝗲𝗮𝘀, but the impact can look very different depending on whether a product is evaluated under the 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭 𝘀𝗲𝗿𝗶𝗲𝘀, 𝗜𝗘𝗖 𝟲��𝟬𝟭𝟬 (𝗳𝗼𝗿 𝗲𝗹𝗲𝗰𝘁𝗿𝗶𝗰𝗮𝗹𝗹𝘆 𝗯𝗮𝘀𝗲𝗱 𝗜𝗩𝗗𝘀 𝗼𝗻𝗹𝘆), or 𝗼𝘂𝘁𝘀𝗶𝗱𝗲 𝘁𝗵𝗲 𝗲𝗹𝗲𝗰𝘁𝗿𝗶𝗰𝗮𝗹 𝘀𝗮𝗳𝗲𝘁𝘆 𝘀𝗽𝗮𝗰𝗲 𝗮𝗹𝘁𝗼𝗴𝗲𝘁𝗵𝗲𝗿, for example 𝗯𝗶𝗼𝗰𝗼𝗺𝗽𝗮𝘁𝗶𝗯𝗶𝗹𝗶𝘁𝘆. 𝗣𝗿𝗮𝗰𝘁𝗶𝗰𝗮𝗹 𝘄𝗮𝘁𝗰𝗵-𝗼𝘂𝘁 𝗳𝗼𝗿 𝗜𝗩𝗗 𝗘𝗠𝗖: 𝗜𝗘𝗖 𝟲𝟭𝟯𝟮𝟲-𝟮-𝟲 𝗘𝗱𝗶𝘁𝗶𝗼𝗻 𝟰 is now 𝗔𝗦𝗖𝗔-𝗹𝗶𝘀𝘁𝗲𝗱, but the real-world benefit depends on 𝗔𝗦𝗖𝗔-𝗮𝗰𝗰𝗿𝗲𝗱𝗶𝘁𝗲𝗱 𝗹𝗮𝗯𝘀 𝗵𝗮𝘃𝗶𝗻𝗴 𝘁𝗵𝗮𝘁 𝘀𝗽𝗲𝗰𝗶𝗳𝗶𝗰 𝘀𝗰𝗼𝗽𝗲. As of checking recently, that scope does not yet appear to be widely reflected, which can create a 𝘁𝗲𝗺𝗽𝗼𝗿𝗮𝗿𝘆 𝗯𝗼𝘁𝘁𝗹𝗲𝗻𝗲𝗰𝗸 𝗳𝗼𝗿 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗲𝗿𝘀 planning to use the ASCA pathway. I’ve reached out to a couple of labs to better understand timing as this develops. Beyond medical electrical and IVD standards, the newly recognized list also spans areas such as 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗶𝗺𝗮𝗴𝗶𝗻𝗴 (𝗗𝗜𝗖𝗢𝗠), 𝗵𝗲𝗮𝗹𝘁𝗵 𝗶𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗰𝘀 𝗮𝗻𝗱 𝗶𝗻𝘁𝗲𝗿𝗼𝗽𝗲𝗿𝗮𝗯𝗶𝗹𝗶𝘁𝘆, and a wide range of 𝗱𝗲𝘃𝗶𝗰𝗲-𝘀𝗽𝗲𝗰𝗶𝗳𝗶𝗰 𝘁𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝗶𝗲𝘀. I’ve published a deeper breakdown that covers • what changed in the FDA database • how 𝗔𝗦𝗖𝗔 𝗲𝗹𝗶𝗴𝗶𝗯𝗶𝗹𝗶𝘁𝘆 fits within FDA’s recognized standards framework • a focused look at the 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭 and 𝗜𝗘𝗖 𝟴𝟬𝟲𝟬𝟭 standards included in this update The full article link is in the comments. A follow-on blog post with the 𝗰𝗼𝗺𝗽𝗹𝗲𝘁𝗲 𝗹𝗶𝘀𝘁 𝗼𝗳 𝗻𝗲𝘄𝗹𝘆 𝗿𝗲𝗰𝗼𝗴𝗻𝗶𝘇𝗲𝗱 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 and additional analysis will follow.

⛔ISO19011 Is Changing: What You Need to Know⛔ #ISO19011, the global standard for auditing management systems, is getting a significant update. The Draft International Standard (DIS) 19011:2025 introduces changes that will impact governance, risk, and compliance (GRC) professionals, particularly those overseeing audit functions. ➡️ What’s Changing in ISO19011? 1. Remote Auditing Is No Longer an Exception, It’s the Norm 🔷What’s new? 🔸The 2025 draft expands guidance on remote auditing, aligning with ISO/IEC TS 17012 (conformity assessment for remote audits). 🔸Organizations conducting virtual audits, hybrid audits, or remote compliance reviews will have clearer best practices. 🔷What this means for You: 🔸If your audit programs still treat remote auditing as a workaround, it’s time to formalize it. 🔸New policies and controls for virtual audits will be necessary to maintain audit credibility. 2. Stronger Risk-Based Approach to Auditing 🔷What’s new? 🔸The 2025 draft elevates risk assessment in audit planning and execution. 🔸Auditors will need to assess risks and opportunities within an audit program before conducting assessments. 🔷What this means for You: 🔸Risk-based auditing is becoming a requirement, not a best practice. 🔸Audit teams should prioritize high-risk areas, integrating audits with enterprise risk management (ERM). 3. Virtual Organizations & Digital Evidence Get Formal Recognition 🔷What’s new? 🔸The draft standard acknowledges “virtual locations”, organizations that operate without a physical footprint. 🔸New guidance covers auditing digital processes, AI-driven decisions, and cloud-based compliance programs. 🔷What this means for You: 🔸Compliance audits must adapt to digital businesses, especially in cloud security, AI governance, and fintech. 🔸Organizations will need new controls for validating digital records and automated compliance tools. 4. Auditor Competency Requirements Are Expanding 🔷What’s new? 🔸The 2025 revision strengthens competency requirements for auditors, including skills in cybersecurity, AI oversight, and remote auditing tools (Shea Brown). 🔸Training and evaluation criteria for audit teams will become more structured. 🔷What this means for You: 🔸Expect more rigorous requirements for internal and external auditors. 🔸Consider upskilling your audit teams now in digital auditing, cybersecurity compliance, and AI governance. ➡️How Should You Prepare? ◽Review Your Remote Auditing Policies – If virtual audits aren’t fully integrated into your audit program, now is the time to refine procedures. ◽Strengthen Risk-Based Audit Planning – Compliance is shifting from a checklist approach to a risk-prioritized strategy. Audit programs should align with enterprise risk frameworks. ◽Update Auditor Competency Requirements – The skills required to audit AI, cybersecurity, and remote environments will be increasingly scrutinized. Ensure your teams are trained and ready. A-LIGN #TheBusinessofCompliance

FDA just updated their Recognized Standards list. Under Section B, FDA announces withdrawals and replacements of recognized standards in the biocompatibility category. These include: 1️⃣ ASTM F1984–25 Whole Complement Activation in Serum by Solid Materials → Updated version recognized   👉 Relevant to ISO 10993-4 effects (blood compatibility, complement activation) 2️⃣ ASTM F2147–01 (Reapproved 2016) Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens → Withdrawn   👉 Sensitization method (historical method; withdrawal may reflect evolving regulatory approach) 3️⃣ ASTM F895–25 Agar Diffusion Cytotoxicity Screening → Updated version recognized   👉 Cytotoxicity (ISO 10993-5 alignment) 4️⃣ ASTM F748–25 Selecting Biological Test Methods for Materials and Devices → Updated version recognized   👉 Strategic biological evaluation planning (aligned with ISO 10993-1 philosophy) 5️⃣ ISO 10993-4:2017 + Amendment 1 (2025) Selection of tests for interactions with blood → Updated recognition   👉 Includes Amendment 1; blood compatibility guidance 6️⃣ ASTM F720–24 Guinea Pig Maximization Test (GPMT) → Updated version recognized   👉 Sensitization 🚫 𝐖𝐡𝐚𝐭 𝐢𝐬 𝐍𝐎𝐓 𝐢𝐧���𝐥𝐮𝐝𝐞𝐝 →No new biocompatibility standards added in Table 2 →No changes to ISO 10993-1 in this specific notice →No new chemical characterization standards added Please share this with your audience! #ISO10993 #biocompatibility • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • If you’re currently working on biological evaluation and would value a second set of experienced eyes, feel free to reach out. I’d be glad to help.

🚨 Did you miss it? EN 60601-1 was updated! The past few months have been a whirlwind of regulatory changes. We saw several guidance documents from the IMDRF and the MDCG, along with notable legislative changes regarding the MDR. But did you catch the update to the European version of IEC 60601-1? 📜 EN 60601-1:2006+A1+A12+A2+A13:2024 was published in May 2024, integrating the latest amendments. This international standard sets the general requirements for the basic safety and essential performance of medical electrical equipment. If you're certifying medical devices in the EU, you know how critical this standard is. ⚙️ What's new? A new Annex ZZ was introduced, mapping the standard's requirements to the General Safety and Performance Requirements of Annex I of the MDR. This means no more guessing which sections cover specific GSPRs. The table simplifies the process for manufacturers and auditors, making it easier to determine if certain GSPRs are fully covered by the standard. ✅ This update is a game-changer. The new Annex ZZ will save time and reduce the complexity in ensuring compliance with the MDR. For manufacturers and auditors, this means a clearer, more straightforward path to certification. 🏆 So, did you notice this change, or is this post the first you're hearing about it? P.S. If you want to save a lot of money when purchasing the standard, then check out the link in the comments. The Estonian Centre for Standardization once again provides a perfect price for value ratio. #medicaldevices #mdr

𝗞𝗲𝘆 𝗨𝗽𝗱𝗮𝘁𝗲𝘀 𝗳𝗿𝗼𝗺 𝘁𝗵𝗲 𝟮𝟬𝟮𝟰 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗔𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 𝗠𝗮𝗻𝘂𝗮𝗹 I have reviewed the Quality Assessment Manual 2024 and wanted to share some insights and key updates. 1️⃣ 𝗕𝗿𝗼𝗮𝗱𝗲𝗻𝗶𝗻𝗴 𝘁𝗵𝗲 𝗦𝗰𝗼𝗽𝗲: 𝗖𝗼𝗻𝗳𝗼𝗿𝗺𝗮𝗻𝗰𝗲 𝗮𝗻𝗱 𝗣𝗲𝗿𝗳𝗼𝗿𝗺𝗮𝗻𝗰𝗲 𝗘𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻 The Quality Assessment will now evaluate not only conformance with standards but also the 𝗽𝗲𝗿𝗳𝗼𝗿𝗺𝗮𝗻𝗰𝗲 of the internal audit function in achieving agreed objectives. The chief audit executive must develop 𝗼𝗯𝗷𝗲𝗰𝘁𝗶𝘃𝗲𝘀, performance criteria, and measurable metrics (e.g., KPIs) with inputs from the board and senior management. 2️⃣ 𝗜𝗻𝘁𝗿𝗼𝗱𝘂𝗰𝗶𝗻𝗴 𝘁𝗵𝗲 𝗙𝗼𝘂𝗿-𝗣𝗼𝗶𝗻𝘁 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗥𝗮𝘁𝗶𝗻𝗴 𝗮𝗻𝗱 𝗖𝗼𝗻𝗰𝗹𝘂𝘀𝗶𝗼𝗻 𝗠𝗼𝗱𝗲𝗹 A revised Four-Point Quality Rating Model has been introduced for more nuanced evaluations. 𝗧𝗵𝗲 𝗿𝗮𝘁𝗶𝗻𝗴𝘀 include: -> Full Achievement (Pass) -> General Achievement (Pass) -> Partial Achievement (No Pass) -> Nonachievement (No Pass) These ratings will be applied for each Standard, Principle and Overall Conformance. 3️⃣ 𝗢𝗽𝘁𝗶𝗼𝗻𝗮𝗹 𝗠𝗮𝘁𝘂𝗿𝗶𝘁𝘆 𝗥𝗮𝘁𝗶𝗻𝗴𝘀 𝗳𝗼𝗿 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗰 𝗜𝗻𝘀𝗶𝗴𝗵𝘁𝘀 For organizations seeking to benchmark and evolve their audit maturity, the manual introduces an 𝗼𝗽𝘁𝗶𝗼𝗻𝗮𝗹 𝗠𝗮𝘁𝘂𝗿𝗶𝘁𝘆 𝗥𝗮𝘁𝗶𝗻𝗴. 𝗧𝗵𝗶𝘀 𝗳𝗶𝘃𝗲-𝘁𝗶𝗲𝗿 𝗳𝗿𝗮𝗺𝗲𝘄𝗼𝗿𝗸 is as follows: ➤ Optimizing (highest level) ➤ Managed ➤ Integrated ➤ Infrastructure ➤ Initial (lowest level) It allows teams to assess their current maturity level and identify areas for growth. 4️⃣ 𝗣𝗲𝗲𝗿 𝗥𝗲𝘃𝗶𝗲𝘄: 𝗔 𝗖𝗼𝘀𝘁-𝗘𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲 𝗦𝗼𝗹𝘂𝘁𝗶𝗼𝗻 Peer reviews involve internal auditors from multiple organizations pooling resources to conduct independent assessments. A minimum of three organizations is required to ensure reviewer independence and objectivity. This alternative is cost-effective compared to hiring external service providers. 𝙄’𝙙 𝙡𝙤𝙫𝙚 𝙩𝙤 𝙝𝙚𝙖𝙧 𝙮𝙤𝙪𝙧 𝙩𝙝𝙤𝙪𝙜𝙝𝙩𝙨 𝙤𝙣 𝙩𝙝𝙚𝙨𝙚 𝙠𝙚𝙮 𝙘𝙝𝙖𝙣𝙜𝙚𝙨!

🚨 𝐌𝐀𝐉𝐎𝐑 𝐈𝐒𝐎 10993-1 𝐔𝐏𝐃𝐀𝐓𝐄𝐒 𝐈𝐌𝐌𝐈𝐍𝐄𝐍𝐓! 🚨 The 2025 revision of ISO 10993-1 is nearing publication, introducing significant changes to the evaluation of medical devices for biological safety. Manufacturers should prepare now, as many regions, particularly Europe, are expected to consider the new standard as State-of-the-Art immediately upon release. 𝐇𝐞𝐫𝐞 𝐚𝐫𝐞 𝐭𝐡𝐞 𝐤𝐞𝐲 𝐬𝐡𝐢𝐟𝐭𝐬 𝐢𝐧 𝐛𝐢𝐨𝐜𝐨𝐦𝐩𝐚𝐭𝐢𝐛𝐢𝐥𝐢𝐭𝐲 𝐞𝐯𝐚𝐥𝐮𝐚𝐭𝐢𝐨𝐧 𝐞𝐱𝐩𝐥𝐚𝐢𝐧𝐞𝐝 𝐟𝐨𝐫 𝐲𝐨𝐮𝐫 𝐢𝐧𝐟𝐨𝐠𝐫𝐚𝐩𝐡𝐢𝐜: 1️⃣ 𝑰𝒏𝒄𝒓𝒆𝒂𝒔𝒆𝒅 𝑭𝒐𝒄𝒖𝒔 𝒐𝒏 𝑹𝒊𝒔𝒌 𝑴𝒂𝒏𝒂𝒈𝒆𝒎𝒆𝒏𝒕 & 𝑬𝒙𝒑𝒆𝒓𝒕𝒊𝒔𝒆 🧐 The standard moves definitively away from a traditional "checkbox approach". • ISO 14971 Integration • Author Qualifications 2️⃣ 𝑹𝒆𝒄𝒂𝒕𝒆𝒈𝒐𝒓𝒊𝒛𝒂𝒕𝒊𝒐𝒏 𝒐𝒇 𝑪𝒐𝒏𝒕𝒂𝒄𝒕 𝑫𝒖𝒓𝒂𝒕𝒊𝒐𝒏 (𝑪𝒖𝒎𝒖𝒍𝒂𝒕𝒊𝒗𝒆 𝑼𝒔𝒆)  🔄 The approach to repeat-use devices has changed significantly, impacting categorisation and required testing. • Cumulative Contact. • Bioaccumulation. 3️⃣ 𝑴𝒂𝒏𝒅𝒂𝒕𝒆 𝒕𝒐 𝑬𝒗𝒂𝒍𝒖𝒂𝒕𝒆 𝑭𝒐𝒓𝒆𝒔𝒆𝒆𝒂𝒃𝒍𝒆 𝑴𝒊𝒔𝒖𝒔𝒆 🤔 Manufacturers must now consider foreseeable misuse—usage that may seem reasonable in a clinical setting but was not initially intended by the manufacturer. • This includes off-label use. • Failure to address foreseeable misuse can lead to regulatory pushback and necessitate reassessing endpoints and potentially repeating costly testing, especially chemical characterisation (ENL). 4️⃣ 𝑺𝒉𝒊𝒇𝒕𝒊𝒏𝒈 𝑩𝒊𝒐𝒍𝒐𝒈𝒊𝒄𝒂𝒍 𝑬𝒏𝒅𝒑𝒐𝒊𝒏𝒕𝒔 🔬 The requirements for specific tests are being adjusted: • Material Mediated Pyrogenicity (MMP) Removal. • Increased Genotoxicity. 5️⃣ 𝑳𝒊𝒇𝒆 𝑪𝒚𝒄𝒍𝒆 & 𝑫𝒆𝒈𝒓𝒂𝒅𝒂𝒕𝒊𝒐𝒏 𝑮𝒖𝒊𝒅𝒂𝒏𝒄𝒆 ♻️ The update includes new guidance on evaluating biocompatibility risks across the entire product life cycle (including prototyping) and clearer requirements for assessing device degradation risks over its useful life. What should you do now? You can start performing a Gap Assessment on your current Biological Evaluation documentation and Quality Management System procedures. This is crucial to identify and prioritise necessary updates before submission, especially if you are pursuing European markets. W̳a̳n̳t̳ ̳a̳ ̳d̳e̳e̳p̳e̳r̳ ̳d̳i̳v̳e̳?̳ 🎧 Listen to the discussion with expert Marina Daineko: https://lnkd.in/eNh8twiN #MedicalDevices #Biocompatibility #ISO10993 #RegulatoryAffairs #MedTech