Indiana Chapter: The New IVDR – Key Information in a Nutshell

RAC Credits
Thursday, 05 September 2019 (5:30 PM) - Thursday, 05 September 2019 (8:30 PM) (Eastern Time (US & Canada))
401 E Michigan St
Indianapolis, Indiana, USA, 46204-1643

*Student: $20
RAPS Members: $30
Nonmembers: $45

*Fax/email in a completed registration form to get the student rate.

Since the new EU Regulation on IVDR came into effect in May 2017, the clock is ticking for all parties involved in the manufacturing of in-vitro diagnostics (IVD). The new regulation introduces more stringent clinical and post-market surveillance requirements for medical device manufacturers, regardless of risk classification. Come join us to learn strategies that can help your IVD device company navigate the higher level of scrutiny, including:

  • General comparison: IVDD vs. IVDR – key changes
  • IVD product classification
  • Annexes II & III – comprehensive Technical Documentation requirements
  • Timeline and impacts to manufacturers and EU market access
  • IVDR readiness considerations for Notified Bodies and manufacturers

This event is coordinated by the RAPS Indiana chapter and is intended to encourage knowledge sharing and community development. Refreshments will be available for all attendees and RAC holders may claim two RAC recertification credits.

Featured Speaker:
Dr. Vivian Ngan-Winward, PhD. medical device product specialist and lead auditor, TUV SUD America