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.

Here are some design validation principles I’ve collected from various resources to help determine what may be appropriate validation techniques for a given scenario:  Design validation follows successful verification and may occur in stages. Certain aspects of design validation can be accomplished during the design verification, but design verification is not a substitute for design validation.  State targeted user needs / intended uses in objective, measurable terms, including acceptance criteria.  Specify the collection of discrete, quantified results that can be objectively measured.  Assure that validation studies include actual or simulated use of the product.  Specify defined operating conditions (i.e., temperature, humidity, shock and vibration, corrosive atmospheres, etc.) where appropriate. Include statistically meaningful sample sizes that are justified.  Validation studies must be performed on initial / pilot production units or their equivalents.