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Compliance to EU MDR General Safety and Performance Requirements (GSPRs) by Application of Standards

6.0
RAC Credits
Tuesday, 01 September 2020 (9:00 AM) - Wednesday, 02 September 2020 (2:00 PM) Eastern Time (US & Canada)

The goal of the workshop is to provide participants with strategies and tools for substantiation of compliance with the General Safety and Performance Requirements (GSPRs) of the EU Medical Devices Regulation (MDR) Annex I by application of international standards. The workshop is interactive, and participants will work hands-on on practical cases. Facilitators and instructors will be notified body experts, consultants, medical device manufacturers and independent laboratory experts.

The workshop will consist of:

  • Brief presentation with explanation of content and background of GSPRs
  • Workshop with attendees on how to show compliance with GPSRs by using standards such as biocompatibility, functional safety, electrical safety, etc. This is the core of the workshop. Participants will be split into two groups: one for non-active devices and one for active devices. This will enable participants to get their specific needs and questions addressed.
  • Plenary closing session with all instructors, which will give participants a broad overview and allow for discussion of any issues that could benefit from the collective, assembled expertise.

Pricing Amounts & Deadlines

6/23/2020 -8/14/2020:  Early Bird $400 Member | $500.00 Nonmember

8/15/2020 – August 29 2020  Regular $500.00 Member | $600.00 Nonmember

 

Objectives

  • Apply strategies and tools for substantiation of compliance with the General Safety and Performance Requirements (GSPRs) in EU MDR Annex I based on (international) standards.
  • Apply specific strategies and tools for substantiation of compliance with the General Safety and Performance Requirements (GSPRs) based on (international) standards for their category of medical devices (active resp non-active)


Agenda

TBD

 

Speakers

Dominik Herzog, Managing Director, TentaMedix GmbH
Christian Johner


Cancellation Policy: All cancellation requests must be submitted in writing to raps@raps.org. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. Should you need to cancel your registration, you can apply your credit to any RAPS program for the next 12 months. Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org. RAPS will allow substitutions up to the first day of the event.


Program Contact

Stephany Evans
Meeting and Events Specialist
Regulatory Affairs Professionals Society® 
Tel: 301 770 2920, ext. 229
5635 Fishers Lane, Suite 400, Rockville, MD 20852 USA


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