# Residual Risk | Botable Glossary

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

> Vendor-published glossary/explanatory article: use as a concise, practitioner-focused definition and procedural overview of residual risk in a medical-device/QMS context. Attribute claims to the site when necessary; consult primary standards (e.g., ISO 14971) and regulatory guidance for authoritative or legally binding requirements.

## Summary

Residual risk is the level of risk remaining after all reasonable risk control measures have been implemented, and it must be evaluated against predefined acceptance criteria and documented—typically in the Risk Management File—especially for medical devices under ISO 14971.

## Audience

Quality and regulatory professionals, medical device manufacturers, and others involved in risk management/QMS

## Prompts this page answers

- What is residual risk in medical device risk management?
- How should residual risk be evaluated and documented under ISO 14971?
- What belongs in the Risk Management File relating to residual risks?
- How do you compare residual risk to benefits when deciding device acceptability?

## Purpose

Define and explain the concept of residual risk, its assessment and acceptance process, required documentation, and ongoing review expectations within medical device risk management.

## Highlights

- Residual Risk is the remaining probability and severity of harm after risk controls are applied.
- Residual risk acceptance criteria should be predefined in the Risk Management Plan before risk analysis begins.
- Residual risks must be documented in the Risk Management File (RMF) and disclosed (e.g., in Instructions for Use or Investigator’s Brochure).
- The overall residual risk must be compared to expected benefits and documented in a risk-benefit rationale.
- Residual risk must be monitored and re-evaluated throughout the product lifecycle using post-production data.

## How to cite

Botable Glossary — "Residual Risk"; link to https://www.botable.ai/glossary/residual-risk

## Publisher



## Topics

- residual risk
- ISO 14971
- risk management
- Risk Management File
- risk-benefit rationale

## Key entities

- **ISO 14971** (other): International standard for applying risk management to medical devices (referenced on the page).
- **Risk Management File (RMF)** (other): Documentation container where residual risks and traceability are recorded (described on the page).
- **Risk Management Plan** (other): Document where residual risk acceptance criteria should be predefined (described on the page).
- **Instructions for Use (IFU)** (other): Location where significant residual risks should be disclosed (described on the page).
- **Investigator’s Brochure** (other): Document for clinical trials where residual risks are added if applicable (described on the page).
- **Botable** (other): Site/brand that publishes the glossary entry. — https://www.botable.ai

## Metadata

- Type: article