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As AI and machine learning continue to revolutionize the medical device sector, understanding and meeting regulatory requirements is more critical than ever

In this video, I discussed the FDA's evolving role in approving AI-powered medical devices and explored the potential impact of AI on healthcare professionals and employers.

𝐈𝐟 𝐲𝐨𝐮 𝐚𝐫𝐞 𝐢𝐧 𝐭𝐡𝐞 𝐀𝐈 𝐒𝐩𝐚𝐜𝐞, you must join me and all the AI experts in Strasbourg on October 1st. Go to the link to see the agenda. We will not talk only about the legislation on AI but also on the way AI for Healthcare software should be documented and how Notified Bodies will check this information. So let me know if you have any questions. #medicaldevice #regulatoryaffairs #easymedicaldevice

📌 AI for Medical Device Manufacturers ✱ The European AI Act is also relevant for medical device manufacturers: https://lnkd.in/gcsfr-dG ✱ Article 6 together with the initial considerations in section (50) suggests that medical devices also fall under the AI Act. ✱ Terms like transparency and explainability are not only buzz words but have to be filled with life. ✱ The German Federal Office for IT Security has issued a whitepaper for this (German language): https://lnkd.in/gCDXgKfb 💡  For more advice about regulatory requirements: https://lnkd.in/gbw4XfiH

Improve documentation accuracy and streamline workflow with AI Medical Scribe, an innovative solution for medical practices. To read more: https://lnkd.in/g3c3yChb #aimedicalscribe #medicalscribe #aihealthcare #doctorassistant #medicaltechnology #clinicaldocumentation #medicine #S10 #S10AI

Expanding on Principle 9 of our prior Good Machine Learning Guiding Principles <https://lnkd.in/e5ek6WBZ> document, Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles <https://lnkd.in/eEi2MJ93> that was just posted is another collaboration with Health Canada and UK's MHRA building consensus on an important topic for AI-enabled medical devices.

Artificial Intelligence in Medical Devices 🤖🩺 The IG-NB and Team-Notified Bodies have jointly published a comprehensive AI Questionnaire, a vital tool for navigating the integration of Artificial Intelligence into medical devices. This initiative addresses critical regulatory and ethical considerations, ensuring that AI-driven medical technologies comply with EU standards while maintaining safety, transparency, and efficiency. 🔍 For organizations developing AI-based medical devices, this questionnaire is a must-read to align innovation with regulatory compliance. 👉 Need guidance? MediCompliance (medicompliance.eu) is here to support you in meeting these complex regulatory requirements and bringing your cutting-edge solutions to market confidently. #MedicalDevices #ArtificialIntelligence #Compliance #MDR #AIRegulations #Innovation

👩⚕️📞With SmartAction, J&B Medical replaced a long, frustrating authentication process with a HIPAA-compliant AI virtual agent – automating more than 75,000 conversations/month and revolutionizing their CX! https://hubs.la/Q02Krw7B0 Read the full case study here: https://hubs.la/Q02KrtKP0

Tune in as regulatory lawyers Cynthia O'Donoghue and Wim Vandenberghe explore the European Union's newly enacted AI Act and its impact on medical device manufacturers. This episode provides valuable insights into AI's role in health care regulation within the EU. #AIexplained #HealthCare #Regulation #EU #MedicalDevices