醫(yī)療器械生產(chǎn)質(zhì)量管理體系（QMS） 咨詢與服務(wù)

          質(zhì)量體系的建立是各國醫(yī)療器械準(zhǔn)入的必備基礎(chǔ)，不同主管當(dāng)局執(zhí)行的質(zhì)量體系標(biāo)準(zhǔn)/法規(guī)存在差異。

          ISO13485是醫(yī)療器械相關(guān)企業(yè)符合歐盟，加拿大，澳大利亞以及其他地區(qū)質(zhì)量體系要求的最常見的途徑和最基礎(chǔ)的要求。

           原CFDA于2014年發(fā)布了《醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范》 (以下簡稱規(guī)范)作為體系考核的依據(jù)。適用于醫(yī)療器械的全生命周期的控制。醫(yī)療器械生產(chǎn)企業(yè)應(yīng)當(dāng)根據(jù)產(chǎn)品的特點(diǎn)，按照規(guī)范的要求，建立質(zhì)量管理體系，并保持有效運(yùn)行。

           FDA按照21 CFR Part 820法規(guī)的要求對(duì)準(zhǔn)入的醫(yī)療器械生產(chǎn)企業(yè)進(jìn)行體系核查，尤其對(duì)海外進(jìn)口商的核查比率逐年增加。

           巴西主管當(dāng)局，按照BGMP要求，對(duì)申請(qǐng)準(zhǔn)入的企業(yè)進(jìn)行體系核查。

           我公司可針對(duì)下列質(zhì)量管理體系提供整合服務(wù)，包括供應(yīng)商審核、企業(yè)自身體系差異性分析、體系的建立以及不符合的關(guān)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(yī)療器械生產(chǎn)質(zhì)量管理規(guī)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(yī)療器械生產(chǎn)質(zhì)量管理體系（QMS）

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