体系跟踪服务

System tracking service

法规要求：The regulations requirements:

医疗器械监督管理条例、医疗器械注册管理办法、医疗器械生产监督管理办法、医疗器械生产质量管理规范、 医疗器械飞行检查办法等，均明确了质量体系有效运行的重要性，也明确了日常检查、飞行检查、企业自查的相关法规依据。

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. 　　

质量管理体系的重要性：The importance of quality management system ：

质量管理体系涵盖了产品研发、生产、质检、销售及售后等各个环节，是保证医疗器械产品进入市场流通的强制性要求，是实现对医疗器械全生命周期控制，保障医疗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.　　

华光泰和公司提供的服务：Services provided by Medadmt ：

全球多国质量管理体系咨询服务（ISO13485、QSR820、MDR、MDSAP等）；

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

医疗器械生产质量管理规范（有源、无源、无菌、植入、IVD）等方面的咨询服务；

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

辅助企业梳理“综合管理-研发-生产-质量-销售及售后”等各环节流程，为产品的全生命周期管理奠定坚实的基础。

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. 　　

服务内容   Service content

定期体系、法规（包含新颁布或修订的法规）及技能培训，规范培训管理并形成记录；

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

每年度的内审和管理评审的现场审核，并规范审核记录及审核文件；

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

行政监管部门或第三方审核不合格的整改，规范管理并形成记录；

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

日常的监督检查，督促企业按照既定的程序要求开展工作，并形成记录归档；

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

监管部门要求的资料上报（包括自查报告），与监管部门的沟通等工作。

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