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  • I actually just wrote and performed both verification procedures as well as validations for the current company I work at. FDA does not mandate a specific way verifications are performed, they just mandate in their 510k or PMA submissions that in verifications, design outputs meet the design inputs. Verification must verify each requirement and pass in order for the requirement to be transferred. The FDA does not view any of the verifications, they usually stay in house in the company as documentation that provides evidence that yes the design input and output was successfully verified. However, in a FDA audit before the transfer and manufacturing phase they would certainly vet through procedures, documentations, and verifications to note if the company is ready or not to being manufacturing a device.