Chicago Chapter Webcast: EU IVDR Update

2.0
RAC Credits
Chapter Events Chapter Events
Monday, 13 June 2022 (11:00 AM) - Monday, 13 June 2022 (1:00 PM) Central Time (US & Canada)

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 credit.


REGISTRATION FEES & DEADLINES

Enterprise Member: Free
RAPS Member: Free
Nonmember: $25


LEARNING OBJECTIVE

  • Understanding the current challenges to IVDR implementation
  • Be better prepared to succeed in the CE marking of diagnostic devices under IVDR
  • Have an opportunity to ask questions about current EU IVDR implementation status

A live Q&A portion with the speaker will follow the presentation.


WHO SHOULD ATTEND?

Any industry representative that is either in the EU now or intending to pursue medical device commercialization in the EU.

  • QA and RA in the medical device industry
  • Anyone operating or interested in the EU

AUDIENCE LEARNING LEVEL

Learning Level: Intermediate


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. A live Q&A portion with the speaker will follow the presentation.


RAPS MEMBERSHIP

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.


Instructors:

Julien Senac, Ph.D.

Julien Senac, Ph.D.
Global Director - IVD Focus Team at TÜV SÜD

 


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 to raps@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance at the following the webcast.

Questions

Contact the RAPS Support Center:

Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org

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