6-Hour Virtual Seminar

6-Hour Virtual Seminar on The New EU Medical Device Regulation

This Seminar will look at what to expect when the new regulation is implemented. Including: the transition period, Effect on Notified Bodies, Impact of the MDR on Quality Management Systems (QMS), technical documentation, clinical trial requirements, UDI and combination products.

Salma Michor
Instructor:
Salma Michor
Date:
Wednesday, May 26, 2021
Time:
08:00 AM PDT | 11:00 AM EDT
Duration:
6 Hours

More Trainings by this Expert   Product Id : 503771

Price Details
$545 Live
$745 Corporate Live
$595 Recorded
$945 Corporate Recorded
Combo Offers
Live + Recorded
$912 $1140 Live + Recorded
Corporate (Live + Recorded)
$1352 $1690 Corporate
(Live + Recorded)
Price Detail Options
Overview:

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 Seminar will look at what to expect when the new regulation is implemented. Including: the transition period, Effect on Notified Bodies, Impact of the MDR on Quality Management Systems (QMS), technical documentation, clinical trial requirements, UDI and combination products.

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

Agenda:

  • 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.


You Recently Viewed