Monday, 26 February 2018
8:30–11:00 am EST
Cerenovus (Formerly Codman Neurovascular)
6303 Blue Lagoon Drive, Suite #315
Miami, FL 33126
The new European Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) came into force May 2017, with full implementation deadlines set for May 2020 and May 2022, respectively. The MDR will replace the EU's current Medical Device Directive (93/42/EEC) and the EU's directive on active implantable medical devices (90/385/EEC).
This presentation will cover the major changes in the regulatory framework and ways in which device manufacturers are developing plans to meet these changes and to determine the impact on their business.
Topics to be covered during this interactive session will include:
- Overview of MDR
- Impact of MDR on the conformity assessment process
- Impact of MDR on the technical documentation
- New clinical and post-market surveillance requirements
The RAPS Florida Chapter invites you to join others from the local regulatory community to explore these changes and discuss what it means for manufacturers and regulatory professionals and explore ways to comply in this ever-changing environment. Continental breakfast will be provided, compliments of EMMA International Consulting Group Inc., and RAC holders may claim two RAC recertification credits.
Jai Li, lead auditor, TÜV SÜD America, Inc.
RAPS Members: $20