Vistatec Life Sciences - In Focus - Ep 21 - María Mateos - Andrei Ninu

Описание: Regulatory expert Andrei Ninu joins Host María Mateos in this episode of Life Sciences - In Focus to discuss one of the most complex challenges facing the medical device industry today: navigating the dual requirements of the EU Medical Device Regulation (MDR) and the newly enacted EU AI Act.

Ninu, who specializes in functional and software safety, as well as AI applications in healthcare, offered a practical and grounded perspective on what these overlapping regulations mean for manufacturers, particularly those developing AI-powered medical technologies.


00:00 - Meet Andrei Ninu: Regulatory Expert in AI and Medical Devices
01:41 - MDR vs. EU AI Act: Understanding the Dual Compliance Landscape
03:59 - Why 80% of MDR Documentation Helps with AI Act Compliance
08:11 - AI Model Training
10:45 - Compliance Tips for Small and Mid-Sized MedTech Companies
14:35 - Real-World Example: Data Partitioning and Clinical Relevance
19:58 - Going Beyond Accuracy: Metrics that Truly Matter in AI Evaluation
25:03 - Final Advice: Engage Early with Notified Bodies for Success

About Life Sciences - In Focus
Life Sciences - In Focus Podcast by Visatatec, a fascinating conversation with global life sciences experts. The show has multiple hosts and topics. Follow Life Sciences - In Focus on Spotify for all the latest episodes, or subscribe to the show on YouTube and Apple podcasts. Life Sciences - In Focus is available on many other podcast platforms. To learn more about the podcast, please visit https://vistatec.com/life-sciences-di....

About Vistatec
We have been helping some of the world’s most iconic brands to optimize their global commercial potential since 1997. Vistatec is one of the world’s leading global content solutions providers. HQ in Dublin, Ireland, with offices in Mountain View, California, USA. To learn more about Vistatec, please visit https://www.vistatec.com

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