How do I produce a medical device ready for the market?


Location: imec, Kapeldreef 75, 3001 Leuven, room beneath the cafeteria (Room -1A), 06/11/13
13:30u-14:00u: Registration
14:00u-14:05u: Welcome (Frederik Horemans, Project Coordinator GENEESS, DSP Valley)
14:05u-14:45u: The role of Notified Bodies in Medical Device development (Bart Mersseman, Product Manager Medical Devices, SGS)
14:45u-15:25u: An introduction to the complex world of Medical Device standards and directives (Bart Leekens, Consultant & Professional Trainer, Allanta)
15:25u-16:00u: When does software become a medical device? (Sofie van der Meulen, advocate, Allanta)
16:00u-16:20u: Break
16:20u-16:45u: Medical devices and Nano-electronics (Filip Ponsaerts, Program Operations & Development, cEDM/imec)
16:45u-17:20u: Experience @ a SME: Functional safety in Medical Devices (Yves Arys, Managing Director, Ninix)
17:20u-18:30u: Informal networking
In the GENEESS project a very informative seminar was organized with the following theme “how do I produce a medical device ready for market”. During this seminar the following topics were discussed: Notified bodies, ISO, Medical device directives, medical software, good manufacturing… There was also a testimonial from a SME regarding their experiences bringing a medical device to the market. They highlighted some pitfalls and points of attention.
Here you can download the presentations:

Some impressions