4BetterDevices

Bad clinical evaluations: spot them at a glance! Flawed clinical evaluations plan SOTA in the CEP, and only report SOTA results in the CER. ➜ Why is this a serious mistake? Because the CEP relies on SOTA information to define: "𝘢𝘯 𝘪𝘯𝘥𝘪𝘤𝘢𝘵𝘪𝘷𝘦 𝘭𝘪𝘴𝘵 𝘢𝘯𝘥 𝘴𝘱𝘦𝘤𝘪𝘧𝘪𝘤𝘢𝘵𝘪𝘰𝘯 𝘰𝘧 𝘱𝘢𝘳𝘢𝘮𝘦𝘵𝘦𝘳𝘴 𝘵𝘰 𝘣𝘦 𝘶𝘴𝘦𝘥 𝘵𝘰 𝘥𝘦𝘵𝘦𝘳𝘮𝘪𝘯𝘦, 𝗯𝗮𝘀𝗲𝗱 𝗼𝗻 𝘁𝗵𝗲 𝘀𝘁𝗮𝘁𝗲 𝗼𝗳 𝘁𝗵𝗲 𝗮𝗿𝘁 𝘪𝘯 𝘮𝘦𝘥𝘪𝘤𝘪𝘯𝘦, 𝘵𝘩𝘦 𝘢𝘤𝘤𝘦𝘱𝘵𝘢𝘣𝘪𝘭𝘪𝘵𝘺 𝘰𝘧 𝘵𝘩𝘦 𝘣𝘦𝘯𝘦𝘧𝘪𝘵-𝘳𝘪𝘴𝘬 𝘳𝘢𝘵𝘪𝘰" of the device as required by MDR Annex XIV for the CEP, IVDR Annex XIII for the PEP. ➜ The Only Exception There is only one (rare) exception to this. When the medical field cannot be identify throught medical literature alone. In such cases, manufacturers must investigate the clinical background. Such investigations are planned in the CDP in the CEP. All this and much more in our SOTA guidance coming next week!

Ramadam Kareem!

Thank you to Monir El Azzouzi from Easy Medical Device and Cesare Magri from 4BetterDevices for organizing the IA Act Summit, a highly insightful event on the application of the AI Act to medical devices, and to all the speakers! Here are some key takeaways for manufacturers of medical devices incorporating AI: 🔹 𝗧𝗶𝗺𝗲𝗹𝗶𝗻𝗲 𝗔𝘂𝗴𝘂𝘀𝘁 𝟮, 𝟮𝟬𝟮𝟳: Mandatory application of the AI Act requirements for medical devices classified as 𝗵𝗶𝗴𝗵-𝗿𝗶𝘀𝗸 𝘀𝘆𝘀𝘁𝗲𝗺𝘀 under this regulation. 🔹 𝗡𝗼𝘁𝗶𝗳𝗶𝗲𝗱 𝗕𝗼𝗱𝗶𝗲𝘀 • As of today, no Notified Bodies have been designated for the AI Act yet. It is therefore recommended to contact the NB to check if they plan to engage in this process. • The 𝗰𝗼𝗻𝗳𝗼𝗿𝗺𝗶𝘁𝘆 𝗮𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 process for medical devices will be 𝗲𝘅𝘁𝗲𝗻𝗱𝗲𝗱 due to the additional time required to assess the AI Act. 🔹 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗦𝘆𝘀𝘁𝗲𝗺 So far, medical device manufacturers must have a 𝗤𝗠𝗦 compliant with 𝗜𝗦𝗢 𝟭𝟯𝟰𝟴𝟱, which includes a quality policy. With the AI Act, an 𝗔𝗜𝗠𝗦 (AI Management System) compliant with 𝗜𝗦𝗢 𝟰𝟮𝟬𝟬𝟭 will also be required, which includes, for example, an AI policy, similar to the quality policy but specifically focused on AI management. 🔹 𝗧𝗲𝗰𝗵𝗻𝗶𝗰𝗮𝗹 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 • While the MDR 2017/745 and the AI Act share some similarities, they are not identical. The AI Act introduces additional elements: - Data governance - Accessibility requirements - Human oversight - GDPR compliance statement • Some contradictions exist between the AI Act and MDR 2017/745, especially regarding technical documentation. The AI Act allows for a lighter file in some cases, while the MDR imposes stricter requirements. Additionally, the 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗼𝗳 𝗱𝗮𝘁𝗮 𝘂𝘀𝗲𝗱 𝗶𝗻 𝗔𝗜 𝘀𝘆𝘀𝘁𝗲𝗺𝘀 is a key focus in ensuring reliable and safe performance. • A 𝗿𝗶𝘀𝗸 𝗮𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 specific to AI, compliant with 𝗜𝗦𝗢 𝟮𝟯𝟴𝟵𝟰, must be conducted. Unlike 𝗜𝗦𝗢 𝟭𝟰𝟵𝟳𝟭, which focuses on 𝗽𝗮𝘁𝗶𝗲𝗻𝘁 𝗵𝗮𝗿𝗺, this analysis addresses risks like 𝘁𝗿𝘂𝘀𝘁𝘄𝗼𝗿𝘁𝗵𝗶𝗻𝗲𝘀𝘀, 𝗽𝗲𝗿𝗳𝗼𝗿𝗺𝗮𝗻𝗰𝗲, 𝗮𝗰𝗰𝗼𝘂𝗻𝘁𝗮𝗯𝗶𝗹𝗶𝘁𝘆, 𝘀𝗲𝗰𝘂𝗿𝗶𝘁𝘆, 𝗮𝗻𝗱 𝗳𝗮𝗶𝗿𝗻𝗲𝘀𝘀. 🔹 𝗔𝗜 𝘀𝘆𝘀𝘁𝗲𝗺 • The 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗼𝗳 𝘁𝗿𝗮𝗶𝗻𝗶𝗻𝗴 𝗱𝗮𝘁𝗮 is crucial for ensuring the safety and reliability of AI systems in medical devices. The data must be accurate, representative, and relevant to the AI model's intended use. • Additionally, the 𝗾𝘂𝗮𝗻𝘁𝗶𝘁𝘆 𝗼𝗳 𝗱𝗮𝘁𝗮 required for training varies depending on the specific function of the medical device. Some devices may need large datasets to ensure accuracy and performance, while others may function with smaller, highly curated datasets. These new requirements highlight the importance of early preparation to ensure compliance and the safety of medical devices incorporating AI.

And we are live with the AI act summit. Great virtual conference organised by Monir El Azzouzi and Cesare Magri with their teams, starting us all on a leaning path, potentially also helping shape our future. Shown slide is from Fabrizio Maniglio

🔜 𝐀𝐈 𝐀𝐂𝐓 𝐒𝐮𝐦𝐦𝐢𝐭 - 𝐒𝐏𝐄𝐀𝐊𝐄𝐑𝐒 😃 This October 1st, these speakers will talk about Artificial Intelligence within the Medical Device field. Thanks to all of them for their participation. 💠Vincent Castéras - nexialist 💠Stéphane Berger - Avicenna.AI 💠Dr. Julia Moosbauer - deepc 💠Soufiane Zakaria AZDAD, M.D. - Algoscope 💠Richie Christian - wega 💠María Diez Zaera - CMG MedDev 💠Gert Bos, PhD, FRAPS - Qserve Group 💠Florian Tolkmitt - PRO-LIANCE GLOBAL SOLUTIONS GmbH 💠Fabrizio Maniglio - Honeywell 💠Cyrille Michaud - MD101 💠Fabien Roy - Hogan Lovells 💠Cesare Magri - 4BetterDevices 💠Thomas LOMMATZSCH - AFNOR Certification 📅 Check the agenda to see what they will discuss and when this will start. The hours are in CET, Central European Time. So don't forget to put that on your calendar ➿ We are finalizing the event organization, but you can still register here: https://lnkd.in/eDKMTKYD #medicaldevice #aiact #aiactsummit #samd #eumdr Easy Medical Device

🙏300+ participants to the AI ACT Summit. I really thank you for that 🙏 Thanks also to 4BetterDevices who are organizing that with me. And to the Easy Medical Device the team. We are all preparing the technical part for the event so join now with the link below. 👍Https://medtechconf.com #medicaldevice #regulatoryaffairs #aiactsummit #aas2024 Cesare Magri

😍 𝐖𝐇𝐀𝐓 𝐈𝐒 𝐓𝐇𝐄 𝐀𝐈 𝐀𝐂𝐓 𝐒𝐔𝐌𝐌𝐈𝐓?😍 Cesare Magri and Monir El Azzouzi explain what you will get through the AI ACT Summit. 🔗 𝑹𝒆𝒈𝒊𝒔𝒕𝒆𝒓 𝒉𝒆𝒓𝒆: https://lnkd.in/eDKMTKYD #medicaldevice #easymedicaldevice #regulatoryaffairs

Don't miss the discussion I had with Cesare Magri on the PMCF literature search method. I think this will help many people to start from the basis and then deliver the right content forward. Check the Software EVIDENCE as there is a trial period. #medicaldevice #easymedicaldevice #regualtoryaffairs

🎉 𝐌𝐨𝐫𝐞 𝐭𝐡𝐚𝐧 100𝐭𝐡 𝐩𝐚𝐫𝐭𝐢𝐜𝐢𝐩𝐚𝐧𝐭𝐬 𝐫𝐞𝐠𝐢𝐬𝐭𝐞𝐫𝐞𝐝🎉 This is the first edition of the AI ACT SUMMIT and we just wanted to thank you as we had some difficulty organizing that on-site and decided to make it online. But apparently, this permits people from all over the world to participate. Thanks also to all the speakers for their support. Don't forget to register so you will be able to see the conference and also ask your questions. https://lnkd.in/eDKMTKYD #medicaldevice #aiact #eumdr #regulatoryaffairs #conference Easy Medical Device 4BetterDevices Cesare Magri

🌟 𝐄𝐱𝐜𝐢𝐭𝐢𝐧𝐠 𝐍𝐞𝐰𝐬! 𝐉𝐨𝐢𝐧 𝐮𝐬 𝐚𝐭 𝐭𝐡𝐞 𝐀𝐈 𝐀𝐜𝐭 𝐒𝐮𝐦𝐦𝐢𝐭 𝐭𝐨 𝐞𝐱𝐩𝐥𝐨𝐫𝐞 𝐡𝐨𝐰 𝐀𝐈 𝐢𝐬 𝐫𝐞𝐬𝐡𝐚𝐩𝐢𝐧𝐠 𝐭𝐡𝐞 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞 𝐥𝐚𝐧𝐝𝐬𝐜𝐚𝐩𝐞. 💡 🔎 𝐀𝐠𝐞𝐧𝐝𝐚 𝐇𝐢𝐠𝐡𝐥𝐢𝐠𝐡𝐭: 𝑨𝒄𝒕 3: 𝑨𝑰 𝑹𝒆𝒈𝒖𝒍𝒂𝒕𝒐𝒓𝒚 𝑪𝒐𝒏𝒔𝒊𝒅𝒆𝒓𝒂𝒕𝒊𝒐𝒏𝒔 𝑷𝒂𝒏𝒆𝒍 𝑫𝒊𝒔𝒄𝒖𝒔𝒔𝒊𝒐𝒏 𝘐𝘴 𝘈𝘐 𝘤𝘩𝘢𝘯𝘨𝘪𝘯𝘨 𝘵𝘩𝘦 𝘱𝘳𝘰𝘤𝘦𝘴𝘴 𝘰𝘧 𝘔𝘦𝘥𝘪𝘤𝘢𝘭 𝘋𝘦𝘷𝘪𝘤𝘦 𝘊𝘦𝘳𝘵𝘪𝘧𝘪𝘤𝘢𝘵𝘪𝘰𝘯? 🎙️ Moderated by: Gert Bos, PhD, FRAPS - Qserve Group 📢 Speakers: Cesare Magri María Diez Zaera Cyrille Michaud Vincent Castéras 🗓️ Don’t miss out on this insightful discussion as industry experts dive into the evolving regulatory landscape and the impact of AI on certification processes. Let’s discuss how these advancements are shaping the future of medical devices. 🔗 Register now and secure your spot! https://lnkd.in/eKfXGGWN #AI #MedicalDevice #RegulatoryAffairs #AIACTSummit #MedicalDevicesAndAI #ArtificialIntelligence #DigitalHealth #HealthcareInnovation #AIMedicalDevices #MedicalDeviceCertification #Compliance #RegulatoryCompliance #HealthTech #AIinHealthcare #MedTech #MedTechInnovation #CECertification #FDARegulations #MedicalDeviceRegulations #MachineLearning #HealthcareAI #MedicalDeviceDevelopment #DigitalTransformation #QMS #RiskManagement