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Post Market Surveillance in Europe

6.0
RAC Credits
Tuesday, 17 November 2020 (9:00 AM) - Tuesday, 17 November 2020 (3:00 PM) Eastern Time (US & Canada)

With the imminent approach of EU MDR's implementation deadline, companies that sell Medtech products within the EU need to prepare for drastic change. Meeting the new regulations' demands, especially for post-market surveillance, will consume more time and resources than ever before. Companies should investigate the available tools and technologies for achieving post-market surveillance compliance effectively and efficiently in preparation. Gain an in-depth understanding and learn actionable tips and strategies for saving time and money while achieving post-market surveillance compliance under the new EU MDR. The one-day virtual event will cover:

  • post-market surveillance best practices
  • when the new PMS requirements apply
  • why updating documentation is critical
  • the responsibilities of economic operators.

 

Pricing Amounts & Deadlines

16 Oct. 2020- 16 Nov 2020:  Regular $750 Member | $850 Nonmember

 

Objectives

Participants will be familiar with:

  • post market surveillance best practices
  • when the new PMS requirements apply
  • why updating documentation is critical
  • the responsibilities of economic operators.

 

Who Should Attend?

Regulatory affairs professionals (entry level, specialists, managers and directors)

 

Agenda

TBD

 

Speaker

Annette van Raamsdonk, LL.M., regulatory affairs manager, Emergo

Annette van Raamsdonk, LL.M. gained significant experience with a broad variety of medical devices working at TÜV Rheinland and serving as Inspector of Medical Technology at the Dutch Health and Youth Care Inspectorate (IGJ). She represented the IGJ within the European Competent Authorities working group for Compliance and enforcement and is currently main contact person towards European Competent Authorities. Areas of expertise include European medical device legislation, borderline issues, classification of medical devices and Competent Authority supervision. Over the past years, van Raamsdonk has been intensively involved in the implementation of the Medical Device Regulation (EU) 2017/745 (MDR) and In vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR), and contributed to European guidance documents (among others PMS guidance and Annex XVI Common Specification) on the MDR. She also participates in several EU working groups of the European Commission and national working groups.

 

Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

All cancellation requests must be submitted in writing via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title.

Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org. 

 

If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org.

Register