12:30-13:00 Arrival – Obtain your batch from reception

13:00-13:05 Opening – Jaakko Lähteenmäki, VTT

13:05-13:25 Medical Software in Transition 2020-2022: MDR, AI & CI/CD – Tommi Mikkonen, University of Helsinki / University of Jyväskylä Presentation Slides

13:25-13:40 MDR approved analysis service, aspects of operations & business, Case Bittium – Tuulia Nissinen & Antti Siipola, Bittium Presentation Slides

13:40-13:55 MDR from private health care service provider perspective – Jani Hopia, Terveystalo Presentation Slides

13:55-14:10 ML/AI compliance – Tuomas Granlund, Solita Presentation Slides

14:10-14:40 Coffee Break & Networking

14:40-14:55 Introducing Design Controls as a Service – Pasi Ahola, Taipuva Consulting Presentation Slides

14:55-15:10 Software as a Medical Device -The IVDR Challenges – Timo Pellinen, Mylab Presentation Slides

15:10-15:25 Secondary use of health data in Kanta for research – Klaus Förger, Atostek Presentation Slides

15:25-15:40 Regulatory challenges in healthcare innovation development – Jaakko Lähteenmäki, VTT Presentation Slides

15:40-16:00 Discussion and seminar closure

16:00-17:00 Networking over some eats & drinks

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