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.

In 175 pages of eye straining text, you’ll encounter unfamiliar rules and terms… expanded General Safety and Performance Requirements… increased requirements for risk management and post-market surveillance… and much more.

You have until May 2020 to comply.

James Pink, a device expert with extensive EU experience, brings his expertise to you.

Presentation Takeways:

  • The new MDR classification system: How to apply the system
  • 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

The new EU-MDR is a handful. It will change how you do business everywhere in the world.

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, Vice President, NSF Health Sciences Medical Devices, Europe

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.