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.
Here’s a taste of what this webinar will cover:
Who Should Attend
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
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....
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