IVDR: Now is the Time for Implementation

12.0
RAC Credits
Virtual Programs Virtual Programs Europe Europe
Thursday, 10 September 2020 (9:00 AM) - Friday, 11 September 2020 (2:00 PM) Eastern Time (US & Canada)

It is crucial for regulatory professionals to know how to implement the requirements of the EU In Vitro Diagnostics Regulation (IVDR ) within their companies to be assured of obtaining CE marking in time to meet the IVDR deadline.

The format is organized as a workshop on how to fulfill the requirements of the IVDR rather than a presentation of the IVDR requirements and objectives. Roughly 85% or more of the IVD products currently on the market are self-certified and have not been scrutinized by a notified body, but will require notified body oversight for IVDR CE certification. The workshop will look at what we know and have learned since last year, building the new requirements and processes into the QMS to support pre- and postmarket devices, and know the extent of IVDR technical documentation and handling of "legacy data" to successfully assemble a technical documentation file.

The workshop is aimed at professionals who are already familiar with the IVDR and are looking to build practical experience. Participants will benefit from working on challenge exercises and hands on case studies, structured to stimulate discussion and activity on the topic or project.


Pricing Amounts & Deadlines 

6/23/2020 -8/14/2020:  Early Bird $800.00 Member | $900.00 Nonmember

8/15/2020 – 9/7/2020:        Regular $900.00 Member | $1200.00 Nonmember


Objectives

  • Apply the new parts of the IVDR required to make their their Quality Management System operational
  • Determine the extent of IVDR Technical Documentation and handling of "legacy data" to successfully assemble their Technical Documentation file for submission

 

Click here to download the agenda


Speakers


RAPS Online Workshop Experience

Join from anywhere to advance your continuing education goals and earn RAC credits. Secure and high-quality live online classroom experience. Interactive tools to foster collaboration. Peer-to-peer engagement and support from instructors.


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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