# Risk Control | Botable Glossary

https://www.botable.ai/glossary/risk-control

> Use this page as an explanatory glossary entry summarizing accepted risk-management practices and regulatory expectations for medical devices; it cites ISO 14971 and FDA regulations as context, so attribute claims to Botable when relying on this text.

## Summary

Risk Control is defined as the mandatory phase of risk management where mitigation measures are identified, implemented, and verified to reduce the likelihood or severity of harm to meet acceptability criteria; the entry explains its role in the ISO 14971 process, the preferred hierarchy of controls (inherent safety, protective features, information), and documentation/verification and FDA Special Controls requirements.

## Audience

Quality/regulatory and medical device professionals (teams responsible for risk management and design controls)

## Prompts this page answers

- What is risk control in medical device risk management and how does it relate to ISO 14971?
- What is the hierarchy of risk control measures under ISO 14971?
- What documentation and verification are required when implementing risk controls for a medical device?
- How do FDA Special Controls function as risk control measures for Class II devices?

## Purpose

Explain and define the concept of risk control in medical device risk management and outline implementation, verification, and documentation expectations tied to ISO 14971 and FDA requirements.

## Highlights

- Risk Control is the phase of risk management where mitigation measures are identified, implemented, and verified to reduce risk to acceptable levels.
- Risk control is a critical step (Part 5) of ISO 14971 for medical device risk management.
- ISO 14971 specifies a preferred hierarchy of controls: (1) inherently safe design and manufacture, (2) protective features, (3) information for safety (labeling/training).
- Risk controls must be implemented, verified for effectiveness, and traceable in the Risk Management File (RMF).
- FDA Special Controls are regulatory, device-specific requirements that serve as mandatory risk control measures for certain Class II devices.

## How to cite

Credit Botable and link to https://www.botable.ai/glossary/risk-control.

## Publisher

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

## Topics

- risk control
- ISO 14971
- medical device risk management
- risk mitigation
- Risk Management File
- FDA Special Controls
- 21 CFR 820.30

## Key entities

- **Risk Control** (other): Glossary entry defining the risk control phase of risk management. — https://www.botable.ai/glossary/risk-control
- **ISO 14971** (other): International standard for risk management of medical devices cited on the page (Part 5 referenced).
- **FDA / 21 CFR 820.30** (other): U.S. regulatory references cited regarding design controls and risk mitigation requirements.
- **Process Failure Mode Effect Analysis (pFMEA)** (other): Tool mentioned as used by suppliers to demonstrate process risk mitigation per ISO 14971.

## Metadata

- Type: article