Quality system is the cornerstone of the development of medical device companies. Ouxing Medical provides medical device companies with China GMP (including sterility, implantation, IVD, software, etc.), ISO13485 (including MDR, IVDR), QSR820, MDSAP and other quality management systems. Services such as regulatory training, certification coaching, and simulation audits:

1) Assess the gaps in the company's current quality management system, assist the company in establishing/improving domestic GMP/ISO13485/QSR820/MDSAP and other quality management systems, and draft/review quality system documents;

2) Provide training on quality management system documents and regulations to enterprises, and promote the operation of the system;

3) Guide enterprises to conduct internal audits and management evaluations of quality management systems, and assist enterprises in maintaining the continuity and effectiveness of quality management system operations;

4) Simulate audits to check the effectiveness of the system and correct deficiencies in the company's existing quality system;

5) Accompany the company to participate in the entire process of on-site audit by the Food and Drug Administration/Third Party Certification Notification Body/FDA, assist the company in making rectifications and successfully pass the audit.

Eu-star Medical provides professional quality system management services for enterprises. Welcome to consult and cooperate. Contact email: info@eu-star.email.