Most recent
ANSI/AAMI/ISO 14971:2019
Medical devices - Application of risk management to medical devices
Specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
Content Provider
Association for the Advancement of Medical Instrumentation [aami]