个性化骨植入医疗器械质量控制及技术评价研究

Research on quality control and technology evaluation of personalized orthopedic implant medical devices

目的 对个性化骨植入医疗器械质量控制及技术评价提出相关建议,以期为监管机构和生产企业等相关人员提供指导和参考。方法 立足于个性化骨植入医疗器械的特点,依照医疗器械安全和性能的基本原则,汲取风险管理意识经验,为促进质量控制和技术评价的科学性,从法规体系建设、上市前研究和上市后监管等角度出发,对个性化骨植入医疗器械的质量控制和技术评价的关注点进行充分探讨。结果 个性化骨植入医疗器械的质量控制应重点关注机构和人员、设备、文件管理、设计开发等方面,技术评价应重点关注个性化骨植入医疗器械的基本特征和实际应用产品的技术评价。结论 建议完善个性化骨植入医疗器械指导文件的建设,深入个性化骨植入医疗器械上市前研究,加强个性化骨植入医疗器械上市后的监管。

Objective To make relevant suggestions on the quality control and technical evaluation research of personalized orthopedic implant medical devices,with a view to providing guidance and reference for relevant personnel such as regulatory agencies and manufacturing enterprises.Methods Based on the characteristics of personalized orthopedic implant medical devices.In accordance with the essential principles of safety and performance of medical devices,drawing on risk management awareness experience,in order to promote the scientificity of quality control and technical evaluation,from the construction of regulatory systems,pre-market research and post-market supervision,the quality control focus and technical evaluation focus of personalized orthopedic implant medical devices were fully discussed.Results The quality control of personalized orthopedic implant medical devices should focus on the aspects of institution and personnel,equipment,document management,design and development,etc.The technical evaluation should focus on the basic characteristics of personalized orthopedic implant medical devices and the technical evaluation of product.Conclusion It is recommended that to improve the construction of guidance documents for personalized orthopedic implant medical devices,further pre-market study of personalized orthopedic implant medical devices,and strengthen post-market supervision of personalized orthopedic implant medical devices.