EU MDR Risk Management Virtual Workshop


About the Workshop

The EU MDR poses tremendous economic and practical challenges for manufacturers. With deadlines looming, lingering ambiguities, and limited availability of notified body support, companies struggle with implementation. 

The MedTech Intelligence web seminars assemble key industry experts, notified bodies, and EU MDR consultants to share practical strategies and procedures for EU MDR implementation.

The new EU Medical Devices Regulation (EU MDR) will profoundly affect the medical device market in Europe. Implementation deadlines are rapidly approaching. Companies that have not already made significant progress in planning and preparation may be at risk of losing EU product registrations. With notified bodies and consultants understaffed and overcommitted, help will be hard to find. Anyone can read the regulation, but interpretation remains vague in some areas, and even the best prepared companies have large teams struggling with impact analysis, strategy, budgeting, and implementation.

This two half-day virtual event features presentations and panel discussions by speakers from notified bodies and top medical device companies. Pooling knowledge and strategies will help the industry as a whole better plan for the massive and costly upcoming changes.


PROGRAM OVERVIEW 

  • Risk Management and EU MDR – Introduction and Overview
  • ISO 14971:2019– Applicability to EU MDR and other regions of the world
  • Design Controls and Usability (IEC 62366) requirements; Usability overview
  • Application of Risk Management to legacy and new product
  • Post-market surveillance requirements and EU MDR
  • Additional monitoring and trending requirements
  • Application of post-market surveillance
  • Risk Management and Post-market surveillance

CEU Information

Attendees can earn CEUs. 1 hour of the conference = 1 CEU. MedTech Intelligence will provide you a Certificate of Attendance with the amount of CEU's earned about three weeks after the conference.

MTI's conference CEUs can be applied to your Regulatory Affairs Certification.

SPEAKERS AND DETAILS

 

 

  • When

  • Tuesday, February 18, 2020 - Wednesday, February 19, 2020
    11:00 AM - 5:00 PM

  • Where

  • Virtual Event

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