The New EU Medical Device Regulation


  Duration: 60 Minutes  

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This webinar will explain what to expect when the new regulation is implemented, in this webinar The medical device directives will be updated and replaced by a Regulation.
Salma Michor   Product Id : 501769
  Instructor : Salma Michor

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Overview:

Regulation proposals of the European Commission

Background

In 2012, the Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices. In particular, the Directives on active implantable medical devices (90/385/EEC) and on medical devices (93/42/EEC) are intended to be replaced by a Regulation on medical devices, while the Directive on in-vitro diagnostic medical devices (98/79/EC) is intended to be replaced by a Regulation on the same subject.

The revisions therefore affected all kinds of medical devices including in vitro diagnostic medical devices, from home-use items like sticking plasters, pregnancy tests and contact lenses, to X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.

This webinar will look at what to expect when the new regulation is implemented.

Why should you Attend: Because the current Directive will be significantly altered and replaced by a Regulation which is legally binding on all Member States.

Areas Covered in the Session:

  • The Updated Regulation
  • Implementation Dates and Transition
  • Main Changes and Products Affected
  • Effect on Medical Device Manufacturers

Who Will Benefit:
  • Clinical Trial Managers
  • Regulatory Affairs
  • Medical Officers


Speaker Profile
Salma Michor , PhD, MSc, MBA, CMgr, RAC is founder and CEO of Michor Consulting Schweiz GmbH, serving such clients as Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive. Previously,She worked for Chiesi-Torrex, Wyeth Whitehall Export Croma Pharma GmbH. She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission. She holds a PhD in thermal process engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King’s College, University of London in food technology; and an MBA from Open University, and has earned the RAC (EU), CQA and is a Chartered manager.




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