ISO 14971: medical device risk management

Where it applies

ISO 14971:2019 addresses medical devices, including software as a medical device and in vitro diagnostic devices. It is not a general certification for pharmaceutical software projects.

Acceptability needs defined criteria

The standard requires manufacturers to establish objective risk acceptability criteria. It does not prescribe universal acceptable risk levels.

An RPN or a coloured matrix cannot replace the device-specific assessment, evidence and decisions in the risk management process.

Use the original reference

Check the applicable requirements for your device and market with the responsible quality and regulatory specialists.

This page is a short orientation. It does not reproduce the standard or establish conformity.

Read ISO’s official overview of ISO 14971:2019.