A quality system is the cornerstone of a medical device company's development. Eurostar Medical provides medical device companies with regulatory training, certification guidance, and mock audits for quality management systems such as Chinese GMP (including aseptic, implantable, IVD, and software), ISO13485 (including MDR and IVDR), QSR820, and MDSAP:

1) Assessing the gaps in the company's current quality management system, assisting the company in establishing/improving its domestic GMP/ISO13485/QSR820/MDSAP quality management system, and drafting/reviewing quality system documents;

2) Providing training on quality management system documents and regulations to the company, and promoting the system's operation;

3) Guiding the company in conducting internal audits and management reviews of its quality management system, assisting the company in maintaining the continuity and effectiveness of its quality management system operation;

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

5) Accompanying the company through the entire process of on-site audits by the State Food and Drug Administration/third-party certification bodies/FDA, assisting the company in making rectifications and successfully passing the audit.

Eustar Medical provides professional quality system management services for enterprises. We welcome inquiries and cooperation. Contact email: info@eu-star.email.