医疗器械生产质量管理体系（QMS） 咨询与服务

          质量体系的建立是各国医疗器械准入的必备基础，不同主管当局执行的质量体系标准/法规存在差异。

          ISO13485是医疗器械相关企业符合欧盟及其他地区质量体系要求的最常见的途径和最基础的要求。

           原CFDA于2014年发布了《医疗器械生产质量管理规范》 (以下简称规范)作为体系考核的依据。适用于医疗器械的全生命周期的控制。医疗器械生产企业应当根据产品的特点，按照规范的要求，建立质量管理体系，并保持有效运行。

           FDA按照21 CFR Part 820法规的要求对准入的医疗器械生产企业进行体系核查，尤其对海外进口商的核查比率逐年增加。

           我公司可针对下列质量管理体系提供整合服务，包括供应商审核、企业自身体系差异性分析、体系的建立以及不符合的关闭。

         The establishment of quality system is the necessary basis for medical equipment access. There are differences in the quality system standards / regulations implemented by different competent authorities.

          ISO 13485 Certification is the most common approach and a basic requirement for a firm to demonstrate QMS compliance in EU and other regions .

           In China, primary CFDA issued China Good Manufacturing Practice for Medical Device (trial) (hereinafter referred as GMP). The GMP is the basic principle for medical device manufacturing and quality management system, which is applicable to design development, production, distribution and servicing of medical devices .Therefore, medical device manufacturers shall establish quality management system and keep it effectively per GMP.

           In U.S, FDA has issued 21 CFR Part 820. Medical device manufacturers are required to pass the on-site inspection by FDA, especially for overseas importers.

                   We can provide integrated services. including gap analysis review, quality management system

establishment, internal audit. mock audit and gap closure.

◆ISO 13485: 2016/ EN ISO 13485:2016 & YY/T 0287:2017

◆医疗器械生产质量管理规范 (Good Manufacturing Practices for Medical Device)

◆美国 21 CFR Part 820