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定制式医疗器械对于个性化医疗的发展具有重要的推动作用,但由于该类产品设计生产的特殊性,常规的检测手段和评价方法很难确保产品的安全有效。因此,该类产品,尤其是高风险定制式医疗器械的质量体系和过程控制尤为重要。本文对高风险定制式医疗器械质量体系相关要求进行了初步探讨,如人员、设计控制、原材料、生产设备、生产过程、产品质量控制、文件管理、可追溯等,以期为相关人员提供借鉴。
Customized medical devices play an important role in promoting the development of personalized medicine. However, due to the particularity of the design and production of such products, it is very difficult to ensure the safety and effectiveness of the products by conventional testing methods and evaluation methods. Therefore, the quality system and process control of such products, especially high-risk customized medical devices, are of particular importance. This article has carried on preliminary discussion to the relevant requirements of high risk custom medical device quality system, such as personnel, design control, raw material, production equipment, production process, product quality control, document management, traceability and so on.