Webinar: How to be in compliance with MDR and IVDR by May 2020/2022

Date: March 26th, 2019 at 15:00

In cooperation with MyBlueLabel, Pharma IT can offer a turn-key solution and services that will enable small and medium size medical device companies to comply with new regulations listed above (Read more here LINK). And now we are able to invite interested parties to this webinar, where Kenn Milton of MyBlueLabel and Ea Marie Holst of Pharma IT will walk through the below agenda.

Agenda

  1. Introduction of MyBlueLabel and Pharma IT
  2. Introduction to the new European regulation and what it implies
  3. How can the MyBlueLabel system support the new regulation
    1. Implementation of MyBlueLabel
    2. Implementation of QMS
    3. Support of the Medical Device development and maintenance
  4. How can Pharma IT support Post market requirements
  5. Summary of how MyBlueLabel and Pharma IT can support compliance

MDR/IVDR in short

By May 2020 medical devices companies will have to comply with the new EU Medical Device Regulation (MDR). For Vitro Medical Devices (IVMD) the date is May 2022.

The regulation holds several new and/or increased requirements that must be adhered to:

  • Implementation of a Quality Management System, with a Conformity Assessment
  • New classification system supported by the Conformity Assessment
  • Requirements for CE marking on the device supported by technical documentation
  • Compliance with reporting of clinical investigations and post-market surveillance requirements
  • Appointing an Authorized Representative and/or a Regulatory Responsible

Date and time

Tuesday March 26th at 15.00 CET via skype (you will recieve the invitation by mail after your have signed up for the event)

Where: Via Skype,

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