ISO 14971 — Application of risk management to medical devices
Also known as: ISO 14971:2019, medical device risk management
Specifies the process a manufacturer must follow to identify hazards, estimate and evaluate risks, control them and monitor the result across a device’s lifecycle.
What it covers
| scope | Risk management process for medical devices across the product lifecycleVerified spec[1] |
|---|
What it means in practice
This standard underpins both CE marking and FDA submissions, and it is a process requirement rather than product evidence. It matters because it is the mechanism by which a manufacturer is supposed to notice that something has gone wrong in the field and act on it — post-market surveillance sits downstream of it.
Sources
Numbers match the citations beside each claim above.
Primary sources
- [1]ISO — Online Browsing Platform and standards catalogue — International Organization for Standardization. Accessed 2026-07-22.