Description

The Design Transfer Checklist is a crucial tool utilized in accordance with ISO 13485, an international standard for quality management systems in the medical device industry. This checklist serves as a systematic guide for ensuring the smooth and accurate transfer of a medical device design from the development phase to the manufacturing phase. It outlines specific tasks, requirements, and verification activities that must be completed to facilitate the seamless transition of the design. By using the Design Transfer Checklist, medical device manufacturers can ensure that all necessary steps are taken to transfer the design outputs, including specifications, procedures, and documentation, to the manufacturing environment.