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.

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Design Transfer Procedure

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

Design Transfer Procedure - Overview

The Design Transfer Procedure ensures the product and processes have been properly transferred prior to the commercial release of a medical device. The 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.

Regulatory framework

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.