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MedTech Europe Webinar: Quality Management System

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MedTech Europe is organising a webinar on Quality Management System in relation to the In Vitro Diagnostic Medical Device Regulation (IVDR) and the Medical Device Regulation (MDR).

The event will take place on 13 February 2018 at 15:00 and it will be led by Dr. Eamonn Hoxey.

The webinar will provide you with an overview on the following aspects:

  • QMS obligations of manufacturers
  • Conformity assessment (Annex IX)
  • QMS gap assessment
  • Managing changes to the QMS
  • Linkage with EN ISO 13485:2016
  • QMS requirements not covered in ISO 13485:2016

The presentations (45’) will be followed by a live Q&A session (45’).

For this webinar we are able to host 150 participants. Therefore the principle first come, first serve will apply. The materials, including the recorded version of the webinar, will be shared with members.

How to follow the webinar:

  • Go to the webinar platform

  • Click on “I am a participant” and enter your name

  • Enter the Web Login: 418701574

  • Enter the Participant PIN Code: 80586141


Should you have any questions or would you like to send in advance your questions for the Q&A session, please contact Kacper Olejniczak - k.Olejniczak@medtecheurope.org

Eamonn Hoxey was Johnson & Johnson’s Executive Director for Quality and Compliance covering Europe, the Middle East, Africa and Asia Pacific. Prior to joining J&J, Eamonn spent 16 years with the UK Medical Devices Agency, including six years as Head of Device Technology and Safety. Dr Hoxey has been closely involved in the development of international and European standards for sterilization processes and equipment and quality management systems.

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