How to identify non-conformities on your AI-enabled medical device
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AI is transforming medical device software. While the EU AI Act will impact the field in 2027, AI devices sold in the EU must currently meet MDR/IVDR requirements. This presentation highlights key pitfalls in AI medical device documentation, based on real-world submissions.
Welcome to join our Science for Lunch event, hosted by our supporting partner TÜV SÜD.
Three Takeaways
- Technical Documentation Review – TÜV SÜD perform technical documentation review as part of conformity assessments prescribed by EU MDR (Regulation (EU) 2017/745) on the use of AI in medical devices.
- CE certification – TÜV SÜD provide EU MDR (Regulation (EU) 2017/745) conformity assessments for AI medical devices.
- Trainings – TÜV SÜD provide Medical Device Training Courses.
Speaker
Christian Jensen, Product reviewer at TÜV SÜD MHS DK – special focus on SW and AI.
About TÜV SÜD
TÜV SÜD is a trusted partner of choice for safety, security and sustainability solutions. It specialises in testing, certification, auditing services. Through close to 28,000 employees across over 1,000 locations, it adds value to its customers, inspiring trust in a physical and digital world.