T/CAMDI 040-2020 The special requirements for metal additive manufacturing medical device production quality management system

Scope

Main technical content: Metal additive manufacturing medical devices are widely used in clinical fields, such as orthopaedic implants, dental implants, rehabilitation devices, and various complex surgical instruments. Customized and patient-matched metal additive manufacturing medical devices play an important role in promoting the development of precision medicine and personalized medicine. Due to the special requirements of raw materials and processing techniques for metal additive manufacturing medical devices, their quality systems and process controls are particularly important. This standard specifies the special requirements for the production quality management system of metal additive manufacturing medical devices. This standard applies to metal additive manufacturing medical devices, including implantable medical devices and non-implantable medical devices. This standard mainly proposes special requirements for the production quality management system of metal additive manufacturing medical devices. Other general requirements for production quality management systems should still meet the relevant provisions of the "Regulations on the Production Quality Management of Medical Devices". This standard will not repeat the explanations of these requirements.

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