Design Transfer Procedure | ISO 13485 | FDA QMSR

The ISO 13485:2016 Design Transfer Procedure governs the transfer of a medical device product and related processes from the development phase to manufacturing in advance of product launch and commercialization.

The Design Transfer Procedure provides instruction on the transfer of medical devices from design and development to manufacturing.

The procedure helps the team confirm that the device and its manufacturing processes are ready for commercial release.

Preparing a controlled handoff

Design transfer begins with a defined scope, sending and receiving locations, responsibilities and a master transfer protocol. The team reviews design, process, quality, supplier and device-master-record information to identify gaps before production accepts the design.

Gates and completion

The procedure uses transfer phases and gates to track documentation, equipment, training, qualification and acceptance criteria. Completion is supported by reviewed evidence and a formal transfer record, including any open items that require resolution.

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.

The handoff draws on the overall Design Control Procedure and evidence from the Design Verification and Validation Procedure.

Supplied as editable Microsoft Word documents with related forms in a digital download.

Part of a procedure bundle

This document is also included in Design Control Procedure Bundle. Explore the bundle for the related documents.