Are you a researcher, entrepreneur, policymaker or health professional confronted with the challenges of Medical Device Regulation (MDR)? Our workshop on 7 December 2022 introduces you in all the ins and outs!
Throughout every step in their development and production, medical devices are increasingly subject to laws, regulations, standards and certification processes. This ever-changing regulatory landscape can be quite challenging. Especially for researchers and manufacturers, who have to balance quality with compliance, and groundbreaking innovation with rules rooted in tradition.
Last year, new European rules for medical devices entered into application. Their goal: increasing the safety of patients and ensuring that innovative medical instruments remain available to them. This new MDR affects not only manufacturers, importers and distributors, but also authorized representatives and healthcare professionals.
Where does our workshop on the 7th of December @ the Irish College fit into all this?it provides a clear overview of the essentials of MDRleading field experts will offer tips and tricksit is a unique opportunity to be inspired by personal stories, insights and lessons learned
18:00 Welcome drinks & soup
Bart Geers, Investment Manager Spin‐off & Innovation unit, KU Leuven Research & Development
18:35 Testimony of an entrepreneur
Bart Hermans, co-founder ZENZO (Comate)
19:00 Testimony of an entrepreneur
Pieter Janssen, co-founder VIPUN Medical
19:25 Testimony of an entrepreneur
Sotirios Gakopoulos, Co-founder & Chief Technology Officer at CoMoveIT
19:45 Comfort break
20:00 Experience from Germany: Digital health applications (DiGA) on prescription
Natalie Gladkov, Consultant for digital medical products, BV Med (Berlin, Germany)
20:35 Panel discussion
- Steven Vandeput (Advisor Digital MedTech Assistance, beMedTech)
Ilse Sienaert & Paolo Cardile (Investment Managers Spin‐off & Innovation unit, KU Leuven Research & Development)
Natalie Gladkov (Consultant for digital medical products, BV Med)
Julie Maes (Product Manager, ArtiQ)
Kyun Thibaut (Managing Director, Covartim)
- Moderation by Bart Geers, Investment Manager Spin‐off & Innovation unit, KU Leuven Research & Development
20:55 Networking with Food & Drinks
initiative of KU Leuven Research & Development and Smart Hub Flemish Brabant, in collaboration with Leuven.Inc.
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We also facilitate collaboration and innovation between companies, knowledge institutes and government within the Leuven Innovation Region, and we are happy to guide any of these stakeholders towards innovation.