For medical device product development, Design Verification demonstrates through objective evidence that the product design meets the requirements (see 21CFR820.3(aa)). Design Verifcation is a defining moment in a project–or at least it should be. The goal of Design Verification is to prove that you designed the product correctly. Verification often represents a critical point for product development: either the design works or it doesn’t. Getting projects to the point of Design Verification is a worthy cause. However, realize that Design Verification activities represent a significant increase in costs compared to product development activities to date. Be sure the product design is ready. It’s really no fun to perform Design Verification activities only to have something go wrong. Poor execution and not being thorough prior to Design Verification will lead to timeline delays, extra expenses (time and testing), and raise questions about the integrity of the team.
To be sure you are ready, here is short checklist of items to address before traveling down the Design Verification path:
- Are Design Input Requirements defined, reviewed, and approved?
- Are Design Input Requirements objective, clear, concise, and verifiable?
- Are Design Outputs (i.e. specifications, drawings, schematics) defined, reviewed, and approved?
- Are Design Outputs in a form that is verifiable?
- Has Acceptance Criteria been defined for all Design Outputs?
- Have Risk Management activities been initiated and documented?
- Has a Design Verification Plan been defined, reviewed, and approved?
- Are Design Verification methods (i.e. test, inspection, analysis) determined?
- Have protocols been defined, reviewed, and approved for Design Verification methods?
I’m sure there are more questions and issues to consider. However, a “no” answer to any of the above questions means the project is not quite ready for Design Verification. A good reference to consult is the FDA Design Control Guidance (specifically sections C – F for Design Verification specific issues).