A quality management framework for implementing additive manufacturing of medical devices

This paper aims to provide a comprehensive review of the implementation of additive manufacturing (AM) for medical devices. A quality management framework is proposed with discussion on topics such as software and data input, product understanding, AM equipment qualification, process understanding and continuous process verification. The interplay between input materials, process controls, and final outcomes of AM were analysed in the framework of quality management. Opportunities and challenges in implementing AM for medical devices are discussed.