How to Prepare for the New EU Medical Device Regulation

Event Information
Product Format
Prerecorded Event
Conference Date
Tue, Sep 18, 2018
60 minutes
Product Description

For a Smooth Transition to the New EU MDR, Start Complying Now

The new EU Medical Device Regulation (MDR) governing the medical device sector in Europe represents one of the most disruptive changes to affect the industry in recent times. It replaces the previous set Medical Device Directives, and is already in the process of transition. The EU MDR represents not just a major compliance challenge, but also a great opportunity to add value to your business. If your company designs, manufactures, or markets medical devices in the world’s second-biggest medtech market, you have a lot to do in relatively short time to get ready – because noncompliance will be very costly.

Find out about the key changes to MDR in this webinar with regulatory consultant Charles H. Paul, and learn exactly how they will impact your medical device manufacturing business. Explore the contents of the new EMDR regulation, understand how they differ from the current Medical Device Directives – such as in terms of notified bodies, clinical evidence, pre-market, transparency and traceability, governance, and oversight. Get current on conformity assessment procedures, notified body designation, the transition period, and the complex array of regulations – all in simple English.

After attending this webinar, you will know the key changes to the new MDR. Plus, you will be confident in your ability to smoothly transition to the MDR – and ease your compliance burden.

Session Highlights

Here’s a taste of what this webinar will cover:

  • Current state of the MDDs and MDR
  • Transition period
  • Key changes – notified bodies, clinical evidence, pre-market, transparency and traceability, governance and oversight
  • Regulation overview
  • Changes to rules
  • Conformity assessment procedures
  • Notified body designation
  • How this new regulation will impact US companies

Who Should Attend

  • Audit and compliance personnel
  • Risk managers
  • Research and development engineers
  • Vice-presidents, directors, and managers of medical device design functions
  • Medical device marketing personnel

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Charles H. Paul

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence....   More Info
More Events By The Speaker

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