The New EU MDR — Are You Really Ready? - Webinar CD/Transcript

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The New EU MDR — Are You Really Ready?: Your Roadmap to World-Class Implementation of Europe’s New Medical Device Regulation

Ready: The EU medical device regulations are changing.

Set: You have 3 years to become compliant.

Go: Start planning your implementation now.

Three of the most respected medical device experts — Minnie Baylor-Henry, JD, Strategic Advisor at YourEncore, Jon Lange, Principal, Advisory Services of Ernst & Young, and Judith Meritz, JD, Strategic Advisor at YourEncore — are joining with FDAnews to help you develop plans to reach compliance.

This webinar will: 

  • Update you on the current state of the legislation — What does the recent political agreement mean?
  • Highlight the areas of greatest risk and opportunity
  • Provide models for how companies can assess their readiness and prepare
  • Outline a clear path to compliance

Register today and gain strategic advantage over your competitors with this nuts-and-bolts presentation.

The legislation will impact many functions, so the audience is very broad:

  • Quality Managers
  • Quality Engineers
  • Quality Auditors
  • Regulatory Managers
  • Design & Development Managers
  • Design Engineers
  • Production Managers
  • Production Supervisors
  • Manufacturing engineers
  • Members of your transition team
  • Clinical Managers
  • Supply Chain – Mgr and above
  • Safety Managers
  • Commercial Managers
  • C-Suite

Meet Your Presenters
Minnie Baylor-Henry, JD, is a Strategic Advisor to YourEncore and the Medical Devices Practice Lead. Prior to assuming her current role in 2015, she was the Worldwide Vice-President for Regulatory Affairs for Johnson & Johnson’s (J&J) Medical Devices & Diagnostics business.

Jon Lange is a Principal in the Advisory Services practice of Ernst & Young and its EU MDR lead.  He has spent 25+ years leading strategic growth initiatives and business transformation change programs for large and mid-tier life science companies.

Judith Meritz, JD, is a Strategic Advisor and member of YourEncore’s Medical Devices Practice.  Previously, she was the Associate General Counsel at Covidien/Medtronic and specializes in compliance counseling concerning FDA and other international regulatory authority matters.