浅析医疗器械设计和开发过程控制

Analysis of Process Control of Medical Device Design and Development

本文基于ISO 13485:2016《医疗器械质量管理体系用于法规的要求》,将顾客、法规等的要求转化为医疗器械设计开发过程、产品设计开发过程、质量管理体系以及产品实样的过程,从设计、开发策划、输入、输出、评审、验证、确认等阶段在内的产品实现全过程研究,为采购、生产和服务提供测量、分析和改进、产品放行、交付及交付后活动等支持,供医疗器械生产企业设计和开发过程控制参考。

Based on ISO 13485:2016 Medical Device Quality Management System for Regulatory Requirements,the requirements of customers and regulations are transformed into medical device design and development process,product design and development process,quality management system and product sample process. From design and development planning,input,output,review,verify and confirm the product realization process is studied,which including stage for purchasing,production and service provision,measurement,analysis and improvement,product release,delivery and after delivery activities support,such as for medical device manufacturing enterprise design and development process control reference.