醫療器械生產質量管理體系（QMS） 咨詢與服務

          質量體系的建立是各國醫療器械準入的必備基礎，不同主管當局執行的質量體系標準/法規存在差異。

          ISO13485是醫療器械相關企業符合歐盟，加拿大，澳大利亞以及其他地區質量體系要求的最常見的途徑和最基礎的要求。

           原CFDA于2014年發布了《醫療器械生產質量管理規范》 (以下簡稱規范)作為體系考核的依據。適用于醫療器械的全生命周期的控制。醫療器械生產企業應當根據產品的特點，按照規范的要求，建立質量管理體系，并保持有效運行。

           FDA按照21 CFR Part 820法規的要求對準入的醫療器械生產企業進行體系核查，尤其對海外進口商的核查比率逐年增加。

           巴西主管當局，按照BGMP要求，對申請準入的企業進行體系核查。

           我公司可針對下列質量管理體系提供整合服務，包括供應商審核、企業自身體系差異性分析、體系的建立以及不符合的關閉。

         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, Canada, Japan, Australia 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.

           In Brazil, ANVISA has issued RDC 16/2013 Brazil Good Manufacturing Practices (BGMP). Medical device manufacturers are required to pass the on-site inspection by ANVISA prior to Registro Submissions .

           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

◆醫療器械生產質量管理規范 (Good Manufacturing Practices for Medical Device)

◆巴西BGMP RDC 16/2013

◆加拿大CAN / CSA ISO 13485

◆美國 21 CFR Part 820

醫療器械生產質量管理體系（QMS）

咨詢與服務