This document provides guidance and intends to serve as a companion to ANSI/AAMI/ISO 14971:2019 for those performing risk management for machine learning (ML) or artificial intelligence (AI) incorporating medical devices.
Standard for medical device security—Security risk management for device manufacturersstandard by Association for the Advancement of Medical Instrumentation, 12/21/2022
Guidance on the use of agile practices in the development of medical device softwarestandard by Association for the Advancement of...
Water for the processing of medical devicesstandard by Association for the Advancement of Medical Instrumentation, 08/17/2023
Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac...