Christophe Fluteaux

🔒 Cybersecurity in Medical Devices and IVDs: A New Compliance Reality ⚕️💻 The US FDA and the EU MDR make cybersecurity a legal requirement for medical device approvals. What this means for manufacturers: ✅ Any device with software qualifies as a “cyber device” ✅ Cybersecurity data must be included in premarket submissions ✅ Stronger protections = safer patients + greater market trust For medical device makers, compliance is no longer optional – it’s essential for access to the US and EU markets. With global expertise in medical device testing and cybersecurity, TÜV SÜD supports you in meeting these new requirements and strengthening trust worldwide. 🌍 Do you want to know more about regulatory requirements for cybersecurity in the EU and US? Then join our complimentary webinar on 23 September! 👉 Register now: http://spkl.io/6040AurbO #MedicalDevices #Cybersecurity #TUVSUD

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Medical device manufacturers face a pivotal transformation as EU MDR requirements reshape industry dynamics. Four years after full implementation, organizations that approached MDR as a strategic opportunity now enjoy measurable competitive advantages over those that treat it as a regulatory burden. Traditional compliance models prove inadequate for modern medical device development. Innovative manufacturers integrate post-market surveillance into their business intelligence, transform supply chain partnerships, and leverage AI capabilities to drive patient-centric innovation. In this article, we demonstrate how evidence-based development processes stimulate sustainable growth while meeting regulatory requirements across the healthcare technology sector. ➡️https://lnkd.in/gEWz5nGD #MedTechRegulation #EUMDRCompliance #HealthcareInnovation #ThoughtLeadership #HorizonsOnline

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Developing a medical device in a “quiet room” without regulatory support? It may feel faster at first. But in reality, you’re dramatically increasing the risk that your product will never make it to market. Why? ❌ Non-compliance with EU MDR or US Q(M)SR ❌ Missing requirements from IEC 60601, IEC 62304, ISO 14971, … ❌ Nonconformities discovered far too late I’ve seen it too often: brilliant teams with innovative ideas, but no early regulatory check. Months (or even years) of work end up in rework, redesign … or in the garbage bin. 👉 The solution is simple: integrate regulatory and standards checks early. It’s not about slowing you down. It’s about protecting your time, money, and innovation. If this sounds familiar, let’s talk. In just 30 minutes we can review your regulatory strategy and spot gaps before they turn into roadblocks. Do you involve regulatory support early in your development or only when it’s “almost done”? If you found this helpful, feel free to Repost 🔁, follow me Beat Keller for more insights, and click the 🔔 to stay updated.

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✨ CAPA in Medical Devices – Corrective vs Preventive: Know the Difference, Avoid the Mistakes ✨ In MedTech, CAPA is more than a compliance requirement — it’s the backbone of patient safety and device reliability. Still, many organizations stumble on the same pitfalls: ⚠️ Overusing corrective actions while neglecting preventive systems ⚠️ Shallow root cause analysis (often flagged in FDA 483s) ⚠️ Poor documentation of investigations and effectiveness checks ⚠️ Missed trend analysis that could stop issues early ✅ When done right, CAPA delivers: 🔹 Cost avoidance through fewer recalls and warning letters 🔹 Stronger QMS with consistent compliance 🔹 Regulatory confidence during audits 🔹 Greater trust among patients and the market 📢 Join our upcoming webinar on Effective Non-Conformance & CAPA Management in MedTech. 🗓️ Find the details and registration link below: 📍 Europe & Asia: 10th September at 11 AM CET 📍 USA & Latin America: 11th September at 1 PM EST 👉 Register now: https://lnkd.in/dmiXSrtR #CAPA #NonConformance #MedTech #MedicalDevices #QualityManagement #RegulatoryCompliance #PatientSafety #QMS #FDA #ISO13485 #MedicalDeviceIndustry

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🇪🇺 𝗡𝗲𝘄 𝘃𝗲𝗿𝘀𝗶𝗼𝗻 𝗼𝗳 𝘁𝗵𝗲 𝗘𝗨 𝗕𝗼𝗿𝗱𝗲𝗿𝗹𝗶𝗻𝗲 & 𝗖𝗹𝗮𝘀𝘀𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗠𝗮𝗻𝘂𝗮𝗹 Version 4 of the EU manual on borderline and classification under MDR and IVDR was officially published today. It adds over 6 new real-life cases discussed and agreed upon by competent authorities through the Helsinki Procedure, including borderline evaluations and updated classifications. The manual isn’t legally binding — but it’s the go-to reference for: • National authorities • Notified bodies • And yes, manufacturers defending the qualification of their product If you develop borderline products, or anything that doesn’t fit neatly into the MDR definition… this manual is essential reading. Examples: • ❌ Nasal spray with anti-COVID antibodies → Not a medical device, as the main action is immunological • ✅ Root canal irrigation solution → Can be class III MDs, if antimicrobial action is ancillary • ❌ dual action cream with menthol and capsaicin (new) → Rejected as MD, both substances act pharmacologically • ✅ Medical calculators → Class IIa according to rule 11 (software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes) • ✅ medical examination table covers (new) → (Class I) MD, purpose = prevention of disease • ✅ FeNO measuring device → IVD device, analyzes exhaled NO to assess asthma-related inflammation What you should do as a manufacturer: 1. Check your borderline products: any overlap with these cases? 2. Review your justification of intended purpose & mode of action 3. Prepare robust scientific evidence, claims alone aren’t enough anymore The manual makes it clearer: no “regulatory shortcuts” will fly under MDR/IVDR. Need help with borderline analysis, risk classification or technical documentation? We do that for a living at CSDmed. 🔗 𝐋𝐢𝐧𝐤 𝐢𝐧 𝐭𝐡𝐞 𝐜𝐨𝐦𝐦𝐞𝐧𝐭𝐬 💕 𝐄𝐧𝐣𝐨𝐲 ———————————— 𝐂𝐒𝐃𝐦𝐞𝐝 𝐂𝐨𝐧𝐬𝐮𝐥𝐭𝐢𝐧𝐠 𝘢𝘴𝘴𝘪𝘴𝘵𝘴 𝘪𝘯 𝐑&𝐃, 𝐐𝐮𝐚𝐥𝐢𝐭𝐲, 𝐚𝐧𝐝 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝘤𝘩𝘢𝘭𝘭𝘦𝘯𝘨𝘦𝘴 𝘸𝘪𝘵𝘩 𝘢 𝘧𝘰𝘤𝘶𝘴 𝘰𝘯 𝐢𝐧𝐭𝐞𝐠𝐫𝐢𝐭𝐲 𝐚𝐧𝐝 𝐩𝐚𝐭𝐢𝐞𝐧𝐭-𝐜𝐞𝐧𝐭𝐫𝐢𝐜 𝐬𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬. 𝘞𝘩𝘢𝘵 𝘴𝘦𝘵𝘴 𝘶𝘴 𝘢𝘱𝘢𝘳𝘵? 𝘈 𝐜𝐨𝐥𝐥𝐚𝐛𝐨𝐫𝐚𝐭𝐢𝐯𝐞 𝐬𝐩𝐢𝐫𝐢𝐭, 𝘧𝘰𝘤𝘶𝘴𝘦𝘥 𝘰𝘯 𝐝𝐞𝐥𝐢𝐯𝐞𝐫𝐢𝐧𝐠 𝐢𝐦𝐩𝐚𝐜𝐭𝐟𝐮𝐥 𝐬𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬 𝘸𝘪𝘵𝘩 𝘢 𝐩𝐨𝐬𝐢𝐭𝐢𝐯𝐞 𝐨𝐮𝐭𝐥𝐨𝐨𝐤. 𝘊𝘰𝘯𝘵𝘢𝘤𝘵 𝘶𝘴 𝘵𝘰 𝘥𝘪𝘴𝘤𝘰𝘷𝘦𝘳 𝘰𝘶𝘳 𝘢𝘱𝘱𝘳𝘰𝘢𝘤𝘩 𝘢𝘯𝘥 𝘷𝘢𝘭𝘶𝘦𝘴.

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