# Risk Analysis | Botable Glossary

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

> Glossary-style explanatory content intended as an educational reference; useful for understanding definitions, regulatory references, and common practices but not a substitute for primary regulatory texts or certified standards. Attribute regulatory claims to the page when quoting.

## Summary

Risk Analysis is defined as the structured activity of identifying hazards and estimating risk (probability × severity) before mitigation; it is presented as the foundational step in a risk management framework and a mandatory activity in regulated industries such as medical device manufacturing.

## Audience

Quality, regulatory, and product teams in regulated industries (e.g., medical device professionals)

## Prompts this page answers

- What is Risk Analysis in the context of medical device development?
- Which standards require risk analysis for software as a medical device (SaMD)?
- How should a team perform hazard identification as part of a Risk Analysis?
- What records must be kept in the Risk Management File (RMF)?
- When should risk analysis be performed during the design process?

## Purpose

To define and explain the concept, intent, components, regulatory context, and documentation expectations for Risk Analysis as used in regulated product development (especially medical devices).

## Highlights

- Risk Analysis is the activity of identifying hazards and estimating risk (probability × severity) before mitigation.
- Risk Analysis is the initial step within the Risk Management framework and must be performed early in design.
- Risk Analysis is mandatory in regulated industries such as medical device manufacturing and is driven by standards like ISO 14971 and FDA regulations.
- Risk management outputs are required design inputs under ISO 13485 (Section 7.3.3).
- The Risk Management File (RMF) must contain records for all risk management activities and show traceability from hazards to controls.

## How to cite

Credit the Botable Glossary (Botable) page “Risk Analysis” and link to https://www.botable.ai/glossary/risk-analysis.

## Publisher



## Topics

- risk analysis
- ISO 14971
- ISO 13485
- FDA design validation
- Risk Management File
- hazard identification
- risk estimation
- FMEA

## Key entities

- **ISO 14971** (other): Standard cited as applying to medical device risk management and SaMD/IVD cybersecurity review.
- **ISO 13485 (Section 7.3.3)** (other): Standard cited for requiring risk management outputs as design and development inputs.
- **FDA Quality System Regulation (QSR)** (other): Referenced for design validation requirement including software validation and risk analysis (mentions 74(g), 301).
- **Risk Management File (RMF)** (other): Document/record set required to contain records for all risk management activities and demonstrate traceability.
- **Failure Modes and Effects Analysis (FMEA)** (other): Risk analysis tool referenced as used to manage issues proactively in the medical device industry.
- **Botable** (organization): Site/brand hosting the glossary entry. — https://www.botable.ai

## Metadata

- Type: article