RAPS Members: $30
*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.
Dr. Vivian Ngan-Winward, PhD. medical device product specialist and lead auditor, TUV SUD America
Local contact: John Lockwood, ASQ-CQA, CSQE, RAC, RAPS Indiana Chapter
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.
Photo Release: By registering for this program, you acknowledge that your picture may be taken by RAPS agents and consent to the use of your name and likeness by RAPS for any RAPS use as deemed appropriate by the organization.
Cancellation Policy: Registration fees for this event are nonrefundable. Substitutions may be accepted with written approval from RAPS. If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at firstname.lastname@example.org.