The NoBoCap project is hosting its first summit! This event offers you the chance to discuss how the new MDR/IVDR regulatory framework is impacting medtech SMEs, learn how NoBoCap can improve your expertise in these requirements, gain insights into the evolving regulatory environment and participate in workshops.
NoBoCap Community Summit
24-25 September 2024
The Hotel Brussels,
Boulevard de Waterloo 38
The summit takes place over two days with virtual workshops on the afternoon of 24 September, followed by a day of presentations and panel discussions in Brussels on 25 September.
Participation is FREE and open to all MEDVIA members as well as members of other innovation hubs and clusters, NoBoCap Community Members and Partners, Knowledge Partners and Notified Bodies interested in the activities of the community to unlock MDR/IVDR for Innovation.
Program:
24 September
13.00-17.30 Parallel Workshops (virtual):
- NoBoCap E-guided tool for NB codes and matchmaking platform
- NoBoCap post–graduate learning modules MDR / IVDR and C-level course for start-ups
- NoBoCap AI and Regulation – short course by VITO and TEF-health
- NoBoCap current reality – surveys, Pulse report/survey results, facts & figures, and case studies by NoBoCap Community Members (innovation hubs)
14.30-16.00 The Knowledge Partners workshops (virtual)
18.00-19.30 Reception and icebreaker
19.30-21.00 Walking dinner
25 September
8.00-8.30 Registration and breakfast
8.30-9.00 Welcome
9.00-10.00 Impact of MDR/IVDR on innovation and the NoBoCap Community
10.00-11.15 National initiatives, best practices and EU-NoBoCap backbone services
11.15-11.45 Break & exhibition
11.45-12.30 A changing EU regulatory environment – looking at horizontal legislation affecting the medical devices sector and innovation access pathways
12.30-13.15 Lunch & exhibition
13.15-13.45 Keynote: EU initiatives to foster and innovation supportive regulatory environment
- Flora Giorgio, Head of Unit MDR/IVDR, European Commission
13.45-14.45 Panel discussion: The road to making the EU the leading and innovation friendly medical devices/IVD/digital health technologies regulatory system
- Flora Giorgio, Head of Unit MDR/IVDR, European Commission
- Oliver Bisazza, CEO Medtech Europe
- Cristina Bescos, Director of Innovation/ Chief Growth Officer, EIT Health
- Nathalie Seigneuret, Innovative Health
- Hugh Laverty, Innovative Health
14.45-15.00 Coffee break
15.00-15.45 Panel discussion: A change in today’s reality fostered by the NoBoCap community
- NB – BSI Richard Holborow – Global Head of Clinical Compliance
- NB- SGS Geofrey Devisscher – Head of Notified Body
- Innovation agency – TBC
15.45-16.15 Closing and input to Charter of Commitments
16.15-17.30 Networking drinks
Register today and learn more about the NoBoCap tools available to help you navigate MDR/IVDR requirements!
https://nobocap.eu/2024/06/25/summit-by-nobocap-community/
What is NoBoCap?
NoBoCap stands for Notified Body Increased Capacity. This European consortium provides support to companies navigating the regulations around medical devices and in vitro diagnostics. MEDVIA is a founding partner of the NoBoCap project.
