FDA will host a webinar to discuss Cybersecurity quality system considerations on Tuesday, June 14, 2022, from 1 p.m. to 2:15 p.m. EDT. The webinar will focus on the latest and current Cybersecurity Premarket Submissions draft guidance released in April 2022. This draft guidance replaces the 2018 draft version and is intended to further emphasize the...Read More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.