# Design Review | Botable Glossary

https://www.botable.ai/glossary/design-review

> Use as an explanatory glossary entry about regulatory expectations for design reviews in medical-device quality systems. It summarizes 21 CFR 820.30(e) and practical procedural considerations but is not a substitute for reading the regulation or legal/regulatory advice; attribute claims to Botable when quoting.

## Summary

The page defines Design Review as a mandatory, formal, documented meeting required by 21 CFR 820.30(e) during medical device development to evaluate design requirements, verify capability to meet them, identify problems, and record results in the Design History File (DHF).

## Audience

Quality/regulatory professionals and medical device manufacturers

## Prompts this page answers

- What is a Design Review under 21 CFR 820.30(e)?
- Who must participate in a medical device design review?
- What documentation is required for a Design Review and where should it be kept?
- How does Design Review relate to design verification and design validation?

## Purpose

Explain the regulatory definition and procedural requirements for Design Review in medical device development (quality/regulatory guidance).

## Highlights

- Design Review is described as a mandatory, formal meeting required throughout device development.
- The requirement is defined in the Quality System Regulation as 21 CFR 820.30(e).
- Design Reviews must be documented and records retained in the Design History File (DHF).
- Required participants include representatives of all functions concerned, an independent person, and specialists as needed.
- Design Review is considered a form of design verification; a Final Design Review commonly occurs at the end of the Design Output stage.

## How to cite

Credit Botable ("Design Review | Botable Glossary") and link to https://www.botable.ai/glossary/design-review

## Publisher

**PHIFLOW, LLC** — Publisher of the Botable site (company name and address shown in the site footer).

## Topics

- Design Review
- 21 CFR 820.30(e)
- Design History File
- design verification
- medical device development

## Key entities

- **PHIFLOW, LLC** (organization): Company name listed in the site footer as publisher.
- **21 CFR 820.30(e)** (other): Quality System Regulation citation referenced on the page.
- **Design History File (DHF)** (other): Document repository where design review records must be retained (mentioned on the page).
- **Design Output Stage** (other): Development stage referenced as the point for a Final Design Review.

## Metadata

- Type: article