[Exploration of Application of Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices: Take Artificial Joint Products as Example].
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引用次数: 0
Abstract
Through the effective application of Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (EP), to continuously improve the corresponding management tools to ensure the safety and effectiveness of medical device in the quality management system, risk management system, evaluation of safety and effectiveness for the supervision departments and manufacturers. The current status of the application of EP and the application issues are analyzed in the study. Take artificial joint products for example, the idea of using EP in quality management system, risk management system and evaluation of safety and effectiveness is investigated, and several thoughts are proposed. Supervision departments should strengthen the unified understanding of EP, develop requirements according to the classification of medical device，and refine specific execution requirements.
通过《医疗器械和 IVD 医疗器械安全和性能基本原则》（Essential Principles of Safety and Performance of Medical Devices，简称 EP）的有效应用，不断完善相应的管理手段，确保医疗器械在质量管理体系、风险管理体系、安全性和有效性评价等方面的安全性和有效性，为监管部门和生产企业提供保障。本研究分析了 EP 的应用现状及应用问题。以人工关节产品为例，探讨了在质量管理体系、风险管理体系、安全性和有效性评价中应用 EP 的思路，并提出了几点思考。监管部门应加强对 EP 的统一认识，根据医疗器械分类制定要求，细化具体执行要求。
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