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

An FDAnews On-Demand Webinar

Offered for One Day Only, Thursday, July 19, 2018
11:00 a.m. - 12:30 p.m. EDT

Back by Popular Demand!

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.

Now, you can be prepared for all the changes with a new webinar/book combo offer from FDAnews. The webinar will provide clear explanations of the changes and gives you the chance to ask questions of an expert. The book supplies you with instructions and checklists to ensure you have done everything to ensure compliance! You can rest easy knowing that you understand all the changes, and have the documents you need to get your organization ready!

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.

Mark your calendar for July 15 and 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!

PLUS, you’ll receive a copy of our bestselling book: EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing. The report provides:

  • Definitions of key terms in the EU MDR
  • Knowing where to find specific requirements in the 150+ page regulation
  • Checklists that walk you through every aspect of manufacturing, safety and performance  requirements
  • A training tool for employees new to the regulations

EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements is the tool that collects all the requirements, explains them and itemized them in an easy-to-use form to ensure compliance.

The compliance deadline may be in 2020, but don’t kid yourself. The time to start preparing is right now. This webinar/book combo is the perfect start. Sign up today.

Please note; this webinar has been previously recorded and no questions will be taken during the presentation.

Webinar plus Audio Recording/Transcript with BONUS
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Who Will Benefit

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



Meet Your Presenter

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.

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