Historical
AAMI TIR38:2014 (AAMI TIR 38:2014)
Medical device safety assurance case report guidance
This TIR is a safety case development reference for medical device design. The TIR is intended to provide a framework within which experience, insight, and judgment are applied systematically to assure and document the safety of a medical device’s design.
Content Provider
Association for the Advancement of Medical Instrumentation [aami]