Design and development transfer

Design transfer is the point where a design is handed over to production in a form that production can build consistently. ISO 13485 asks for a documented procedure, verification that the design outputs are suitable for manufacturing, and evidence that production capability can meet product requirements, and the results and conclusions are recorded. Gaps at this step often surface later as nonconformities, rework or complaints.

The organization shall document procedures for transfer of design and development outputs to manufacturing.

ISO 13485:2016, clause 7.3.8

Under the FDA's QMSR the requirement is ISO 13485 clause 7.3.8, which took the place of the former 21 CFR 820.30(h), and design controls apply to class II and III devices and to the class I devices listed in 21 CFR 820.10(c). The EU MDR has no separate article on design transfer and relies on the manufacturer's quality management system, usually built on ISO 13485.