"I Don't Need to Validate the Software or Automated Test Equipment Used in Design and Development"

Yes, actually you do. If you are using a software tool or an automated test to perform design or design verification or validation then the data generated is paramount to your understanding of the design or the design verification or validation results. This requirement extends to software tools used to generate medical device software or even the writing of test software for the production environment. 21 CFR Part 820.70(i) requires all software used anywhere within the quality system to be validated for its intended use. This includes software used in design.

If you are using any test method for design verification or validation that has not been previously validated or qualified, you should ensure it is validated or qualified before use. This includes those that may not be automated and is even more important for simulated use testing that you perform for design validation. If you are using a standard method, documented in an approved international or national standard, you would not need to be worried about this except to provide documented evidence that your test set-up met the standard and your performed the test as specified in the standard. If you designed the test method, then perform enough validation (or qualification) activities to prove objectively that the test method will provide data that is appropriate, accurate, repeatable, and reproducible.

Denise Dion is the vice-president, regulatory and quality services at EduQuest, where she provides advice and guidance regarding FDA's regulation of drugs, biologics, medical devices, and food.