科曼的发展是“专科专用”的胜利

An Early Stage of Research on the Requirements on Quality System of High-Risk Customized Additive Manufacturing Medical Devices

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 signifcantly promote the development of customized healthcare. However, subject to the specialty in design and manufacturinof customized medical devices, general testing methods or evaluation tools can hardly ensure the safety and effectiveness. Therefore, quality system anprocedure control have obvious advantages in customized medical devices, especially in high-risk products. This article introduces an early stage of researcon the requirements on quality system of high-risk customized additive manufacturing medical devices, such as human resources, design control, raw materialsmanufacturing facilities, product quality control, and traceability, etc., and we aim to provide reference for relevant personnel.