Technical Information Report 97-2019 Principles for medical device security - Postmarket risk management for device manufacturers
Publication Year
2019
Document Status
Current
Abstract
Guidance on methods to perform postmarket security risk management for a medical device in the context of the Safety Risk Management process.
Document History
Reconfirmed 2023.
Publisher Information
Association for the Advancement of Medical Instrumentation
The Association for the Advancement of Medical Instrumentation (AAMI) is a nonprofit organization founded in 1967 with a membership including industry leaders, healthcare professionals, and government representatives working together to improve patient safety and healthcare outcomes.
