Design Validation frequently gets confused with Design Verification – they are quite different processes, though. With verification, you’re making sure that the product meets the requirements identified by customers and regulations. Validation is where you actually build a functioning version of the product to make sure it performs as expected.
In Section 820.3(z), the FDA states that “there are two types of validation to consider:
- Process Validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.
- Design Validation means establishing by objective evidence that device specifications conform to user needs and intended use(s).”
The concept of validation is intended to ensure that a product, service or system results in an end-product that meets the needs or requirements of the user.
The validation process should be planned for, and considered early in the design process. The design team needs to identify which performance characteristics should be evaluated. The more complex the design, the recommendation is to put together a schedule of validation activities and a timeline/sequence for them to be performed.
While clinical trials are not required for all medical devices, a clinical evaluation is. The medical device should be tested in the environment and manner that it is intended to be used. This should include simulation of anticipated temperature and humidity exposure, corrosive atmospheres and impact of shock and vibration (as seen during shipping) to the product. Also, this testing should be handled in the same method and with the procedures that will be used for actual production. In addition to testing, there are other validation methods that may be used including analysis and inspection methods, compilation of relevant literature, or comparison of similar designs or material as proof that items are clinically safe. Product packaging and labeling are also to be evaluated at this point.
All validation documentation should be referenced in detail in the validation report. This information needs to be included as part of the design history file.