Design Verification

‍Design Verification is the process of confirming, through evidence, that the device design created matches the technical specifications initially written.

Design Verification is a crucial activity within the Design Controls framework (21 CFR 820.30(f)) for medical device manufacturers, serving as a formal check during development.

In simple terms, Design Verification answers the question: "I made the product correctly".

Formal Definition and Core Requirements

The U.S. FDA's Quality System Regulation (QSR), 21 CFR 820.30(f), states that:

• Definition: Design verification means confirmation by objective evidence that specified requirements have been fulfilled. Specifically, Design verification shall confirm that the design output meets the design input requirements.
• Procedures: Each manufacturer must establish and maintain procedures for verifying the device design.
• Documentation: The results of the design verification activities must be formally documented in the Design History File (DHF). This documentation must include the identification of the design, the method(s) used, the date, and the individual(s) performing the verification.

Key Principles and Activities

Design Verification is an internal check that occurs before Design Validation and involves comparing the design's result (Design Output) against the stated requirements (Design Input).

1. Verification vs. Validation Distinction

Design verification focuses on whether the design output meets the design input requirements. This is fundamentally different from Design Validation, which focuses on whether the design conforms to user needs and intended use(s) ("I made the correct product"). Design verification must successfully precede design validation.

2. Methods of Verification

Verification activities must be documented and typically include one or more of the following methods, as they provide objective evidence:

• Performing alternative calculations: This involves using different analytical techniques (e.g., manual calculations versus computer analysis) to check the correctness of the original design parameters or methods.
• Undertaking tests and demonstrations: This could involve testing models or prototypes (often referred to as prototype testing) to confirm performance against specifications.
• Comparing the new design with a similar proven design, if available. This technique could be based on a formal design review meeting or a written report.
• Review of design documents: The Design Review meeting itself is considered a form of design verification. The intent of the Design Verification activity (to determine if the Design Stage output meets the Design Stage input) can be met by conducting a design review meeting.

3. Verification in Design Changes

Design verification procedures are also critical when making alterations to a finished device. Manufacturers must establish procedures for the identification, documentation, validation, or where appropriate, verification, review, and approval of design changes before their implementation.

If Design Controls were used to assess a change, the documentation must include a statement that the verification and validation testing, as appropriate, demonstrated that the design outputs met the design input requirements.

4. Personnel and Documentation

Personnel who perform verification activities must be made aware of defects and errors that may be encountered as part of their job functions.

Documentation of verification results, including identification of the design, method, date, and the individuals performing the verification, must be placed in the Design History File (DHF).

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