July 16, 2021
Showing Conformity to Standards
Regardless of the source of a request for evidence showing conformity with applicable standards, a pivotal underlying fundamental remains the same and drives the answer: Conformance with standards is generally a design/development verification and/or validation activity. Therefore, the general rule of thumb is that there needs to be a verification and/or validation protocol (explaining, among other things, how the verification/validation will be done), and a report to document the results and conclusions. Stick to the principles embodied for example in ISO 13485 clauses 7.3.6 and 7.3.7 and you should be on track. Failure to do this regarding conformity with applicable standards can lead to compliance (and maybe even safety) problems.
It has been said that design verification may involve inspections, tests, examination, demonstration, or other analyses. And although various verification methods may be employed, any verification approach which establishes conformance with a design input requirement is an acceptable means of verifying the design with respect to that requirement. Sometimes we must get creative for this (e.g., via basic visual inspections, document/content review/confirmations, etc.) when the nature of the verification doesn’t warrant actual testing.