Most recent
ANSI/AAMI/IEC TIR80002-1:2009
Medical device software - Part 1:Guidance on the application of ISO14971 to medical device software
Provides guidance for the application of the requirements contained in ISO 14971:2007, Medical devices - Application of risk management to medical devices to MEDICAL DEVICE SOFTWARE with reference to IEC 62304:2006, Medical device software - Software life cycle processes.
Content Provider
Association for the Advancement of Medical Instrumentation [aami]