體系跟蹤服務(wù)

System tracking service

法規(guī)要求：The regulations requirements:

醫(yī)療器械監(jiān)督管理?xiàng)l例、醫(yī)療器械注冊(cè)管理辦法、醫(yī)療器械生產(chǎn)監(jiān)督管理辦法、醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范、 醫(yī)療器械飛行檢查辦法等，均明確了質(zhì)量體系有效運(yùn)行的重要性，也明確了日常檢查、飛行檢查、企業(yè)自查的相關(guān)法規(guī)依據(jù)。

Medical device supervision and management regulations, medical device registration management measures, medical device production supervision and management measures, medical device production quality management practice, medical device flight inspection measures, etc., have clarified the importance of effectiveoperation of the quality system, but also clear the daily inspection, flight inspection, enterprise self-inspection of the relevant laws and regulations. 　　

質(zhì)量管理體系的重要性：The importance of quality management system ：

質(zhì)量管理體系涵蓋了產(chǎn)品研發(fā)、生產(chǎn)、質(zhì)檢、銷售及售后等各個(gè)環(huán)節(jié)，是保證醫(yī)療器械產(chǎn)品進(jìn)入市場(chǎng)流通的強(qiáng)制性要求，是實(shí)現(xiàn)對(duì)醫(yī)療器械全生命周期控制，保障醫(yī)療器械安全有效的重要手段。

The quality management system covers all aspects of product research and development, production, quality inspection, sales and after-sales, which is a mandatory requirement to ensure that medical device products enter the market circulation, and an important means to achieve the full life cycle control of medical devices and ensure the safety and effectiveness of medical devices.　　

華光泰和公司提供的服務(wù)：Services provided by Medadmt ：

全球多國質(zhì)量管理體系咨詢服務(wù)（ISO13485、QSR820、MDR、MDSAP等）；

Global multinational quality management system consulting services (ISO13485, QSR820, MDR, MDSAP, etc.);

醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范（有源、無源、無菌、植入、IVD）等方面的咨詢服務(wù)；

Consulting services on medical device production quality management practice (active, passive, sterile, implantable, IVD);

輔助企業(yè)梳理“綜合管理-研發(fā)-生產(chǎn)-質(zhì)量-銷售及售后”等各環(huán)節(jié)流程，為產(chǎn)品的全生命周期管理奠定堅(jiān)實(shí)的基礎(chǔ)。

Assist enterprises to sort out the processes of "comprehensive management - R&D - production - quality - sales and after-sales" and lay a solid foundation for the whole life cycle management of products. 　　

服務(wù)內(nèi)容   Service content

定期體系、法規(guī)（包含新頒布或修訂的法規(guī)）及技能培訓(xùn)，規(guī)范培訓(xùn)管理并形成記錄；

Regular system, regulations (including newly promulgated or revised regulations) and skills training, standardize training management and record;

每年度的內(nèi)審和管理評(píng)審的現(xiàn)場(chǎng)審核，并規(guī)范審核記錄及審核文件；

On-site audit of internal audit and management review every year, and standardize audit records and audit documents;

行政監(jiān)管部門或第三方審核不合格的整改，規(guī)范管理并形成記錄；

Administrative supervision department or third party audit unqualified rectification, standardized management and record;

日常的監(jiān)督檢查，督促企業(yè)按照既定的程序要求開展工作，并形成記錄歸檔；

Daily supervision and inspection, urge the enterprise to carry out work in accordance with the established procedure requirements, and form records and archives; 　　

監(jiān)管部門要求的資料上報(bào)（包括自查報(bào)告），與監(jiān)管部門的溝通等工作。

Information reporting required by regulatory authorities (including self-inspection report), communication with regulatory authorities, etc.