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Chicago Chapter Webcast: IVDR Notified Body Update

2.0
RAC Credits
Monday, 12 April 2021 (11:00 AM) - Monday, 12 April 2021 (1:00 PM) Central Time (US & Canada)

Member: $10
Nonmember: $25

Description

On 5 May 2017, the European Commission adopted the In Vitro Medical Device Regulation (EU IVDR) 2017/746. Since the publication, additional guidance documents were issued to support the implementation of the regulation. With just over one year remaining before the end of the transition period (26 May 2022), IVD manufacturers have to develop strategic approaches to answer the increased requirements and collect enough data to demonstrate compliance of their devices. Join us for an interactive workshop that will allow participants to hear directly from a leading Notified Body IVDR expert on:

  • The current state of IVDR
  • Impact of COVID-19 on the certification process
  • Experience working on Technical Documentation submitted under the IVDR
  • Postmarket surveillance requirements
  • Review of latest published guidance documents

There will be live Q&A available throughout the presentation. 

This event is brought to you by the RAPS Chicago chapter to encourage knowledge sharing and community development. RAC holders may claim 2.0 RAC recertification credits.

Learning Level: Intermediate 

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity. 

RAPS membership provides vital information for regulatory professionals and a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. Find out more about RAPS membership today.

How Do Webcasts Work?

For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. There will be live Q&A available throughout the presentation. 

Featured Speaker:
Dr. Julien Senac, PhD, global director, IVD Focus Team, TÜV SÜD

Thank you to our Platinum Chapter Sponsors: