The virtual AAMI/FDA/BSI International Conference on Medical Devices (the ISC) will be presented from 10:30 a.m. to 3:15 p.m. (EDT), Monday-Wednesday 18-20 October 2021. As always, the ISC will be a dynamic review of recent changes and a look to what’s ahead in health tech standards and regulation, but this year each day will have...Read More
Updated Risk Management training course now available. Includes:
Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
Why FMEA is incomplete for medical device risk management.