I'm reading 21CFR820, ISO13485, and ISO14969 to clarify for the company the difference between verification and validation.
My question may apply to other medical devices but for a software-only (no hardware at all) medical device, it seems possible, plausible, and defensible to have validation prior to verification.
Alpha software could be tested against use cases and sent to customers to validate the flow/features. Then, the development could finish and all the internal requirements verified. If there were changes in the use cases between the alpha validation version and the final verified version, you could validate just the delta. If there were no changes, no validation.
Has anyone done this and had it pass certification/audit?
Or has everyone just fallen out of their chairs?
Thank you,
S. Schoepel
My question may apply to other medical devices but for a software-only (no hardware at all) medical device, it seems possible, plausible, and defensible to have validation prior to verification.
Alpha software could be tested against use cases and sent to customers to validate the flow/features. Then, the development could finish and all the internal requirements verified. If there were changes in the use cases between the alpha validation version and the final verified version, you could validate just the delta. If there were no changes, no validation.
Has anyone done this and had it pass certification/audit?
Or has everyone just fallen out of their chairs?
Thank you,
S. Schoepel