ISO13485 Medical Device Management System

　　1. Introduction to ISO13485:

　　ISO13485 certification standard is the basic criterion for the production and quality management of medical devices. It is applicable to the key processes affecting the quality of finished products in the whole process of the production of medical devices.

　　2. Requirements for certification:

　　They should have corresponding qualifications (such as business license, organization code, relevant national administrative approval qualification or industry qualification), relevant facilities and resources, and be able to carry out normal business activities. Provide business records for more than three months, strictly abide by the national regulations on medical devices, and possess relevant qualifications.

　　3. Procedures for obtaining certification:

　　The process of obtaining certification is usually divided into two stages.

　　Certification Consulting Stage: After the signing of the contract, our company will send consultant teachers to the enterprise to conduct research, determine the intention of the enterprise's certification, help the enterprise to determine the organizational structure and the division of responsibilities and powers, the coverage of the system, compile and improve the system documents needed for certification, train the personnel of the enterprise, Guide the enterprise to operate according to the requirements of the system documents, and help the enterprise. Application for certification.

　　Authentication and Audit Stage: The auditors sent by the certification bodies will check the activities of enterprises applying for the scope of certification according to the certification standards and enterprise system documents. The emphasis is to verify the situation of enterprises and compile the certification documents and records, and report to the certification bodies for certification at the end of the inspection.

　　4. Benefits of certification:

　　1. It can strengthen the management of medical devices, strengthen the quality control of enterprises, and ensure the personal safety of patients.

　　2. Providing users with stable quality products can improve and improve the management level of enterprises and increase the visibility of enterprises.

　　3. Improve and ensure the quality level of products, so that enterprises can obtain greater economic benefits;

　　4. It is conducive to eliminating trade barriers and obtaining passes to enter the international market. It is also conducive to enhancing the competitiveness of products and increasing their market share.