Join Medicon Valley Medtech Network and our next meeting!
– Required steps to get your medical device on the market
Over the coming years new medtech regulations – Medical Device Regulations (MDR 2017/745) and in-vitro Diagnostic Regulations (IVDR 2017/746) – come into effect and everyone that wish to have a medical device or an in-vitro diagnostic device on the market needs to relate to these requirements. Do you have a strategy for your MDR- and IVDR-transformation?
We are happy to invite new and existing MVA members interested in joining us for our fourth network meeting where you will meet PCG Clinical Services, QAdvis, and SAXOCON, that will offer an overview of strategies to implement the new medtech regulations.
| Date: | 11th of June, 2018 |
| Time: | 17.00- 20.00 |
| Hosts: | Medtech Innovation and SAXOCON |
| Venue: | Meeting room 1, 2nd floor, Meeting Center, Building 101 (Entrance A), Technical University of Denmark, Anker Engelunds Vej 1, Kgs. Lyngby – Map |
Program
| 17.00-17.30 | Registration, networking and a bite to eat – meet the fellow participants |
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| 17.30-17.35 | Welcome Anette Rye Larsen, Project Manager, Medtech Innovation Petter Hartman, CEO, Medicon Valley Alliance |
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| 17.35-17.45 | The key challenges of MDR & IVDR
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| 17.45-18.20 | Clinical evaluation & clinical performance evaluation according to MDR & IVDR Cecilia Emanuelsson, Principal Consultant, QAdvis Nils-Åke Lindberg, CEO, QAdvis |
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| 18.20-18.55 | Clinical investigations – clinical performance and design & importance of Biometrics
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| 18.55-19.25 | Biological safety assessment of medical devices
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| 19.25-19.30 | Wrap up Martin Friis-Mikkelsen, CEO, SAXOCON |
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| 19.30-20.00 | Networking and a light snack |
Deadline for registration is 7th of June, 2018.
For more information please contact Senior Project Manager Helen Pettersson: hp@mva.org
In collaboration
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