ABSTRACT
Design transfer involves the transfer of design documentation as well as knowledge and information regarding suppliers, manufacturing, and inspection processes, in order to help ensure device(s) are reliably and repeatedly produced while maintaining the intended device performance and safety. The transfer of design and process information should be a well-planned process resulting in the issuance of the Device Master Record (DMR)/Medical Device File as part of the design output. Design transfer activities during the development process ensure that design outputs are reviewed and verified as suitable for manufacturing before becoming final production specifications. A design transfer checklist is a helpful tool for ensuring that all required documents are ready/approved for transfer and/or have already been transferred—e.g., DMR. The design transfer checklist should correspond with the outputs associated with the activities identified on the design and development plan. An Engineering Change Order may be used to transfer the final Design History File and remaining DMR elements to Document Control for retention.
