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  • I don’t think there is a specific way that is the “most efficient” way to brings DID specification to the device. It depends on the device type, design team, etc. I would agree with other replies above, which emphasize that engineers would play a big role in determining the right specifications for a device in order to make it pass the validation and verification steps and meet the user (clinician & patient) requirements and needs. Regulatory and marketing members would also assist a lot in managing how well the device will succeed in meeting the relevant standards marketing and regulatory requirements in the individual market that the device will be sold.