European Medical Device Regulations (EU MDR) - Webinar Recording/Transcript

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European Medical Device Regulations (EU MDR): Strategic Planning for the Coming Critical Changes

Devicemakers face a market upheaval in the EU. A new set of rules — the Medical Device Regulation (MDR) — will soon supplant the longstanding Medical Device Directive, forever changing how you sell medical devices in EU nations.

The number of rules will increase from 18 to 22, dramatically impacting what quality and regulatory specialists do every day. Changes in classification rules will require manufacturers to confirm and update documentation to reflect the changes. And this just scratches the surface.

James Pink has spent recent years immersing himself in the details and ramifications of this groundbreaking change. A device expert with extensive EU experience, Mr. Pink now brings his expertise to you.

Join Mr. Pink for 90 minutes of total immersion into the forthcoming changes. You’ll discover:

  • How the aforementioned rules increase, from 18 to 22, could affect your job
  • Documentation confirmation and updating: Specific changes you’ll be required to make
  • New separate software rules and what they say
  • Stricter requirements for implantable devices: The impact on quality and compliance
  • The consequences of delay: Sanctions you could face, markets you could lose
  • And much more!

Once the MDR takes effect, you’ll have three years to adapt to the changes. Don’t kid yourself: The time to start preparing is right now.

This webinar aids everyone with responsibility for medical device regulatory lifecycles, quality management systems design and implementation, or product design and development, including specific responsibilities such as:

  • QA/QC
  • Manufacturing/GMP
  • Designers/engineers
  • Regulatory affairs/compliance
  • Business development
  • Marketing/sales
  • Legal counsel
  • Consultants

James Pink has more than 20 years’ experience in the medical device industry, including 10 years as a health care technology expert and Lead Auditor for a leading European Notified body. He has managed development and quality assurance programs for orthopedic, cardiovascular, wound, and combination products; and presented to the EU competent authorities and expert working groups relating to classification decisions, clinical study design, scientific and technical briefings. A major focus in recent years has been preparing for the advent of the EU Medical Device Regulation.