FDAnews Announces — European Medical Device Regulations (EU MDR) Webinar, July 19, 2018

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The impending EU Medical Device Regulation (MDR) will turn EU markets upside-down. Here’s how to get ready.

FDAnews

FDAnews

European Medical Device Regulations (EU MDR):
Strategic Planning for the Coming Critical Changes
**An FDAnews Webinar**
July 19, 2018 — 11:00 a.m. – 12:30 p.m. ET
http://www.fdanews.com/eumdrondemand

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 they 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, devicemakers 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.

The book supplies instructions and checklists to ensure devicemakers have done everything to ensure compliance.

The webinar will be led by James Pink, who has spent recent years studying the details and ramifications of this groundbreaking change. A device expert with extensive EU experience, Mr. Pink now brings his expertise to attendees.

Attendees will discover:

  •     Documentation confirmation and updating: Specific changes devicemakers will 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 devicemakers could face, markets they could lose
  •     And much more

And, as part of the same product, attendees will receive the FDAnews best-selling book: EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements. The editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements devicemakers can use to confirm that they 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

Don’t wait for the 2020 deadline. The time to start preparing is right now. This webinar is the perfect start, and the book provides the details needed to get compliance right.

Webinar Details:
European Medical Device Regulations (EU MDR):
Strategic Planning for the Coming Critical Changes
**An FDAnews Webinar**
July 19, 2018 — 11:00 a.m. – 12:30 p.m. ET
http://www.fdanews.com/eumdrondemand    

Tuition:
$487 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/eumdrondemand                                
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDAnews
+1 703-538-7660
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