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目的探索《医疗器械生产管理规范(试行)》(简称《规范》)对医疗器械生产企业风险管理的影响。方法对北京市平谷区医疗器械生产企业《规范》认证工作进行探析。结果与结论《规范》对提升医疗器械生产企业风险管理能力,确保上市医疗器械的安全有效发挥了积极的作用。
Objective To explore the impact of “medical device manufacturing management practices (Trial)” (referred to as “norms”) on the risk management of medical device manufacturers. Methods The “standard” certification of medical device manufacturers in Pinggu District of Beijing was analyzed. Results and Conclusion The “Code” has played an active role in enhancing the risk management capabilities of medical device manufacturers and ensuring the safety and effectiveness of listed medical devices.