# Design Verification | Botable Glossary

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

> A vendor-hosted glossary entry explaining regulatory expectations and common verification methods; useful as a concise reference for how Design Verification is described relative to FDA QSR.

## Summary

Design Verification is the process of confirming, with objective evidence, that a device's design output meets the original design input/technical specifications; it is a required activity under the FDA Quality System Regulation (21 CFR 820.30(f)) and its results must be documented in the Design History File (DHF).

## Audience

medical device manufacturers and quality/regulatory teams

## Prompts this page answers

- What is design verification under 21 CFR 820.30(f)?
- How does design verification differ from design validation?
- What must be documented for a design verification activity?
- What methods can be used to perform design verification for a medical device?

## Purpose

To define and explain the regulatory meaning, core requirements, methods, and documentation expectations for Design Verification in the context of medical device design controls.

## Highlights

- Design verification means confirmation by objective evidence that specified requirements have been fulfilled; it confirms design output meets design input requirements (21 CFR 820.30(f)).
- Manufacturers must establish and maintain procedures for verifying the device design.
- Results of design verification activities must be documented in the Design History File (DHF) and include design identification, methods used, date, and individuals performing verification.
- Common verification methods include alternative calculations, tests and demonstrations (e.g., prototype testing), comparisons to proven designs, and design review meetings.

## How to cite

Link to the page should be provided when citing.

## Publisher



## Topics

- design verification
- 21 CFR 820.30(f)
- Design History File (DHF)
- design controls
- design validation

## Key entities

- **Design Verification** (other): Glossary entry defining the term and explaining regulatory expectations. — https://www.botable.ai/glossary/design-verification
- **21 CFR 820.30(f)** (other): The U.S. FDA Quality System Regulation paragraph cited on the page as the governing requirement for design verification.
- **Design History File (DHF)** (other): The required location for documenting design verification results (linked from the page). — https://www.botable.ai/glossary/design-history-file-dhf
- **Design Validation** (other): Related glossary term contrasted with Design Verification on the page. — https://www.botable.ai/glossary/design-validation
- **Botable** (organization): Site branding shown on the page; hosts the glossary. — https://www.botable.ai/
- **Device History Record (DHR)** (other): Next glossary term linked from the page. — https://www.botable.ai/glossary/device-history-record-dhr

## Metadata

- Type: article