Event info
Date:11 Jun
Time:17:00-20:00
Venue:DTU, Kgs Lyngby

Medicon Valley Medtech Network meeting

 

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


Sign up

Program

17.00-17.30Registration, networking and a bite to eat
– meet the fellow participants
17.30-17.35Welcome
Anette Rye Larsen, Project Manager, Medtech Innovation
Petter Hartman, CEO, Medicon Valley Alliance
17.35-17.45The key challenges of MDR & IVDR


Cecilia Emanuelsson
Principal Consultant
QAdvis

Nils-Åke Lindberg
CEO
QAdvis
17.45-18.20Clinical evaluation & clinical performance evaluation according to MDR & IVDR
Cecilia Emanuelsson, Principal Consultant, QAdvis
Nils-Åke Lindberg, CEO, QAdvis
18.20-18.55Clinical investigations – clinical performance and design & importance of Biometrics


Maria Axetun
Project Manager
PCG Clinical Services

Daniel Seisdedos
Clinical Project Manager
PCG Clinical Services
18.55-19.25Biological safety assessment of medical devices


Anders Permin
CTO
SAXOCON
19.25-19.30Wrap up
Martin Friis-Mikkelsen, CEO, SAXOCON
19.30-20.00Networking 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