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

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


    Cecilia Emanuelsson
    Principal Consultant        
    QAdvis

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


    Maria Axetun
    Project Manager
    PCG Clinical Services      

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


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