# ISO 14971 | Botable Glossary

https://www.botable.ai/glossary/iso-14971

> A concise glossary/article-style summary intended as an explanatory reference for practitioners; use it as an introductory or refresher source on ISO 14971 and attribute claims to the Botable glossary entry rather than treating it as a primary normative source (the actual ISO text or regulatory guidance should be consulted for compliance).

## Summary

This Botable glossary article explains ISO 14971 as the international standard that defines requirements and processes for applying risk management to medical devices, describes its lifecycle-spanning approach and documentation requirements (RMP, RMF, traceability), outlines the standard’s cyclical risk-management phases, and highlights the 2019 revision’s emphasis on post-market risk management.

## Audience

Medical device manufacturers, quality & regulatory teams (professionals working on device risk management and QMS integration).

## Prompts this page answers

- What does ISO 14971 require for risk management of medical devices?
- What are the key phases of the ISO 14971 risk management process?
- How does ISO 14971 interact with ISO 13485?
- What documentation does ISO 14971 require (RMP, RMF, traceability)?
- What changes did the ISO 14971:2019 revision introduce regarding post-market surveillance?

## Purpose

To explain and summarize the scope, key principles, phases, documentation requirements, and practical implications of ISO 14971 for medical device risk management.

## Highlights

- ISO 14971 defines requirements and processes for applying risk management to medical devices.
- The standard applies across the entire product lifecycle, from design through post-production monitoring.
- Key documents required include a Risk Management Plan (RMP) and a Risk Management File (RMF) with traceability.
- ISO 14971:2019 increased emphasis on post-market risk management and ongoing review of post-production data.
- Risk control follows a preferred order: inherently safe design, protective features, then information for safety.

## How to cite

Link to the page: https://www.botable.ai/glossary/iso-14971

## Publisher

**Botable** — Publisher of botable.ai.

## Topics

- ISO 14971
- medical device risk management
- risk management file RMP RMF
- ISO 13485 integration
- post-market surveillance

## Key entities

- **ISO 14971** (other): International standard defining requirements and processes for medical device risk management (subject of the page). — https://www.botable.ai/glossary/iso-14971
- **International Organization for Standardization (ISO)** (organization): Standards body referenced as issuer of ISO 14971.
- **ISO 13485** (other): Medical device QMS standard referenced for integration with ISO 14971. — https://www.botable.ai/glossary/iso-13485
- **Software as a Medical Device (SaMD)** (other): Device type explicitly mentioned as within ISO 14971’s scope.
- **In vitro diagnostic devices (IVD)** (other): Device type explicitly mentioned as within ISO 14971’s scope.
- **Failure Mode and Effects Analysis (FMEA)** (other): Risk-analysis method mentioned on the page.
- **Hazard Analysis and Critical Control Points (HACCP)** (other): Analytical method referenced as useful for risk management.
- **FDA** (organization): Regulatory body mentioned as explicitly recognizing ISO 14971.
- **ICH Q9 (Fault Tree Analysis reference)** (other): Referenced for Fault Tree Analysis as a helpful tool.

## Metadata

- Type: article