March 22–23, 2018
The International Conference on Medical Device Standards and Regulations will bring together regulators and standards leaders from around the world to report on some of the latest developments in this arena and discuss how medical manufacturers can prepare to ensure continued global market access and regulatory compliance.
- Recent legislative changes, including the 21st Century Cures Act and the FDA Reauthorization Act of 2017
- FDA guidance related to clinical decision support software and digital health products, including the new software precertification program
- CDRH reorganization, to better align the center to a total product life cycle model
- E.U. Medical Device Regulations, including discussion on conformity assessment and in vitro diagnostics
- The implementation of ISO 13485:2016, Medical devices—Quality management systems—Requirements for regulatory purposes
- The Medical Device Single Audit Program
- The revision of ISO 14971, Medical devices—Application of risk management to medical devices
- Postmarket surveillance
Who Should Attend
- Professionals from medical technology companies who have responsibility for standards and regulatory compliance
- Suppliers to medical device companies
- Industry consultants
Seats are limited, so please register now.
Stay tuned for more details on a separate European conference coming in June 2018.