April 4–5, 2017
AAMI, in partnership with the British Standards Institution (BSI) and the Food and Drug Administration (FDA), presents the Symposium on the Evolving Standards and Regulatory Structure for Medical Devices.
Join colleagues from across the healthcare technology industry to hear about the latest developments in global regulations and standards. Discussions will include:
- Implications of the 21st Century Cures Act
- Preview of Medical Device User Fee Amendments 2017 (MDUFA IV)
- Update on the European Medical Device Regulation (MDR)
- Recent and coming changes to key international standards (ISO 13485, ISO 14971, etc.)
- The shift in regulations and standards to a postmarket focus
Attending the symposium provides attendees the unique opportunity to gain knowledge on the latest standards and regulatory initiatives that affect manufacturers of medical devices—both in the U.S. and abroad.
AAMI, BSI, and the FDA will present subject knowledge experts who will provide the latest information to help attendees reach compliance in this changing regulatory landscape.
Seats are limited, so please register now.
Check back for updates on the agenda, session descriptions, and speakers.