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[Critical Control Points and Case Studies in the Production of Metal Additive Manufacturing Medical Device]
1Shanghai Medical Device and Cosmetics Evaluation and Verification Center, Shanghai, 200020.
Abstract:
The critical control points in the production quality management of metal additive manufacturing medical devices, including personnel, hardware, design and development, procurement control, production management and quality control are summarized from the perspective of supervision. The typical cases are analyzed to provide reference for medical device regulatory authorities and enterprises.
