In the quality management of implantable medical devices,product retention samples are an important measure for post-market quality traceability,aligning with the requirement for continuous quality monitoring of such products.This paper analyzes the risks associated with surrogate retention samples of metal orthopedic implantable medical devices,based on the legal requirements set forth in regulations such as the Regulations on the Supervision and Administration of Medical Devices and the Measures for the Supervision of Medical Device Production.It also explores potential control measures to provide a reference for enterprises to conduct surrogate sample retention.
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