1. Regulatory requirements：

　　Articles 22 to 24 of the regulations on the supervision and administration of medical devices (Order No. 650 of the State Council) respectively specify the requirements and key points for the quality system verification of medical enterprises, as well as the requirements for the long-term and effective operation of the quality system. In addition, it has successively issued medical device registration management measures, medical device production supervision and management measures, medical device production quality management specifications and professional appendix, inspection guiding principles, medical device flight inspection methods, etc., all of which have made clear the importance of effective operation of the quality system, as well as the relevant regulatory basis for daily inspection, flight inspection and enterprise self inspection.

　　2. The importance of quality management system

　　The quality management system covers all aspects of product development, production, quality inspection, sales and after-sales. The construction of the system is a mandatory requirement to ensure the market circulation of medical devices, and an important means to realize the whole life cycle control of medical devices and ensure the safety and effectiveness of medical devices.

　　3. Services provided by Huaguang Taihe company

　　Huaguangtaihe can provide consulting services for medical device enterprises in the aspects of global multinational quality management system (ISO13485, qsr820, MDR, mdsap, etc.), and the quality management specification of medical device production (active, passive, sterile, implanted, IVD), and assist enterprises to sort out & "and; Integrated management, R & D, production, quality, sales and after-sales; And other processes, help domestic and foreign medical device manufacturers identify the requirements of domestic medical device production quality management standards, and integrate them into their own quality management system, and lay a solid foundation for the whole life cycle management of products.

　　Whether it comes from the reform of the domestic pharmaceutical regulatory department or the adjustment of laws and regulations, enterprises need to accept more and more inspection, the pressure of sustainable development is increasing, and the management risk becomes very complex. In this case, our long-term tracking coaching service can effectively help you manage the risks caused by the operation of the quality system. We can help you to ensure compliance with regulatory requirements. We still need some specific services to meet your business requirements. Our professional consultants are dedicated to help you. Through the cooperation with Huaguang Taihe to develop service plan, you can effectively protect the company brand, improve trust and get more relevant parties' approval.

　　4. service content

　　1、Regular system, laws and regulations (including newly promulgated or revised laws and regulations) and skill training, standardize training management and form records;

　　2、Annual internal audit and on-site audit of management review, and standardize audit records and audit documents;

　　3、The administrative supervision department, the third party audit unqualified rectification, and standardize the management, form records;

　　4、Daily supervision and inspection, urge the enterprise to carry out the work according to the established procedure requirements, and form records for filing;

　　5、Report the information required by the regulatory authorities (including self inspection report), and communicate with the regulatory authorities.