Contact Person
    Helen Pettersson

    Senior Project Manager
    Email: hp@mva.org
    Phone: (M) +45 2337 0040
    LinkedIn

    Medicon Valley Medtech Network meeting

     

    Join Medicon Valley Medtech Network and our next meeting!
    Understanding Biocompatibility of Medical Devices
    – biological evaluation and biocompatibility testing according to ISO 10993

    Medical device manufacturers must conduct biological safety (biocompatibility) evaluations for their medical devices to meet regulatory obligations and receive approval to market medical devices. The complexity of this process is increasing due to new regulatory requirements. Do you have an updated strategy for the biological evaluation of your medical device products?

    Welcome to join us at the next Medicon Valley MedTech Network meeting to learn more about ISO 10993* and the recent changes in the standard, and understand how to make a biological evaluation of your medical device products:

    Date: 2nd of October, 2018
    Time: 17.00- 20.00
    Host: SenzaGen AB
    Venue: Auditorium, Medicon Village, Lund

    * ISO 10993; Biological Evaluation of Medical Devices – is the most widely used standard for assessing the biocompatibility of medical devices and materials, and provides a framework for determining the appropriate biocompatibility steps for planning a biological evaluation. Specific testing is dependent on the type of medical device or material and its intended use, and on the nature and duration of contact between the medical device and the body.

    The Network
    Joining the network is free of charge and is limited to Medicon Valley Alliance members. However, non-member organizations and companies are welcome to attend one network event to evaluate if being part of the network is relevant. If so, becoming a member of Medicon Valley Alliance will automatically able you to join the medtech network.

    Sign up

    Program
    Moderator: Rose-Marie Jenvert, Project Manager, SenzaGen AB

    17.00-17.30 Registration, networking and a bite to eat
     – meet the fellow participants
    17.30-17.35 Welcome
    Petter Hartman, CEO, Medicon Valley Alliance
    Kerstin Jakobsson, CEO, Medicon Village Innovation
    17.35-17.40 Sponsor of the event
    Peter Borg Gaarde, Partner & European Patent Attorney, HØIBERG P/S
    17.40-18.15 Introduction to Biocompatibility and ISO 10993
    Monica Grekula, Business Area and Team Manager Toxicologist, Symbioteq
    18.15-18.35 Chemical characterization according to ISO 10993-18
    Carsten Senholt, Principal Toxicologist, SAXOCON
    18.35-18.55 Industry perspective on hemocompatibility testing according to ISO 10993-4
    Barbara Musi, Principal Research Scientist Toxicology & Biocompatibility, Baxter
    18.55-19.25 Case study: Medical Device Biocompatibility Testing
    Helge Gehrke, Head of in vitro Pharmacology and Toxicology, Eurofins Biopharma Product Testing Munich
    19.25-19.30 Presentation of a business delegation from the Swiss Jura region
    Gustav Henriksson, Head of Trade Section, trade Point Nordics, Embassy of Switzerland in Sweden
    Jacques Gerber, Minister of economic affairs, Canton Jura
    19.30 Wrap up
    Rose-Marie Jenvert, Project Manager, SenzaGen AB
    19.30-20.00 Networking and a light snack

    Deadline for registration is 27th of September, 2018.

    For more information please contact Senior Project Manager Helen Pettersson: hp@mva.org

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