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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]

Others Also Bought
Medical devices - Quality management systems - Requirements for regulatory purposes
Medical device software - Software life cycle processes - Amendment only
Medical devices - Guidance on the application of ISO 14971
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Document History
Amendments & Corrections
We have no amendments or corrections for this standard.