The AAMI/BSI/FDA International Conference on Medical Device Standards and Regulation will be held on 24-25 April 2019 at the Hyatt Regency Reston, 1800 Presidents St, Reston, VA 20190. The conference will provide updates and analysis of new FDA initiatives and European Medical Device regulation and will review changes to key international standards
Planned sessions will review:
- Key FDA programs and initiatives, such as the standards recognition program, the digital health initiatives, and the single file program
- Implementation of the European Medical Device Regulations (including the implications of Brexit)
- The status of the Medical Device Single Audit Program, including a case-study of one manufacturer’s experience with MDSAP
- Review of new guidance from the International Medical Device Regulators Forum, including guidance on the use of standards to support regulation and the new Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices
- The future of Quality Management Systems, including the proposed FDA switch from 21 CFR 820 to ISO 13485 and prospective eventual alignment of ISO 13485 and ISO 9001
- New cybersecurity laws or standards affecting medical devices from around the world.
- Implications of the upcoming new edition of ISO 14155, Clinical investigation of medical devices for human subjects
- The use of a full Product Life Cycle Approach in medical device regulations and standards
- A review of progress in standards for health software and health IT (including the new provisional AAMI HIT1000 series for health IT systems, revision of IEC 62304 for health software and revision of the IEC/ISO 80001 series for medial IT systems)
- Overview of developing standards and regulatory approaches governing artificial intelligence and machine-learning algorithms in medical technology.
Breakout sessions will address developments in standards or regulations for UDIs, mobile applications and wearable devices, Amendment 2 to IEC 60601-1, the ISO 10993 biocompatibility series, sterile packaging, robotics, and combination products.
Book your hotel room today at the Hyatt Regency Reston: click here!
The deadline to receive the AAMI discounted hotel rate is Tuesday, April 2, 2019