1. Understand the implementation points and countermeasures of the GMP and on-site inspection guidelines for medical device production, and general requirements;

2. Understand the implementation points and countermeasures of medical device production quality management standards and on-site inspection guidelines, training on special requirements for sterility, implantation, IVD, dentures, and software;

3. Professional training for the verification and confirmation of the medical device production quality management standard process;

4. Professional training for medical device unannounced inspection case analysis, improvement measures, and system self-inspection ability improvement;

5. Responsibilities, authority and ability requirements of managers' representatives required by regulations to improve the company's management level, advanced training courses;

Professional training course on quality management standards for medical device operations.

1. ISO 13485 and ISO 9001 internal auditor training (first forensics class, standard version change, renewal registration class);

2. ISO 13485 and medical device production quality management practice self-inspection internal auditor training;

3. ISO 14971 and ISO 24971 risk management standard training (basic general courses, advanced application seminars);

4. YY/T 0664-2020 "Medical Device Software Software Life Cycle Process" standard training course;

5. YY/T1406.1 software product risk management application professional training;

6. YY/T0316 Appendix H professional training on risk management application of in vitro diagnostic reagent products;

7. ISO 13485 and medical device production quality management standards for quality management system establishment and document preparation training courses;

8. ISO 13485 and medical device production quality management practices internal audit procedures, methods, skills and self-inspection improvement training courses;

9. YY/T 0595-2020 Medical Device Quality Management System YY/T 0287-2017 Application Guide;

10. Internal auditor training for EU EN/ISO13485 and China Good Manufacturing Practice for Medical Devices;

11. Internal auditor training for QSR820, ISO13485 and China Quality Management Practice for Medical Devices in the United States;

12. MDSAP single system audit, regulation training;

1. The implementation of the new GB9706.1 standard and the practical skills training for electrical safety inspectors;

2. The new version of Pharmacopoeia and sterility inspection (chemical) laboratory personnel practical skills training;

3. YY0505 standard implementation of common unqualified problems analysis and treatment measures skills training;

4. Skill training in clean workshop clean technology, clean workshop environment control, aseptic sterilization confirmation, packaging confirmation, etc.;

1. "Implanted" enterprise internal audit class (professional training is carried out according to the products produced by the enterprise);

2. "Implanted" industry risk management class (professional training based on the products produced by the enterprise);

3. "Implanted" enterprise GMP and GSP special training courses (professional training is carried out according to the production and operation of products of the enterprise);

4. Track and improve training services (combined with the development stage of the enterprise, carry out professional training on basic knowledge, daily system operation, effective operation, operation improvement, etc.);

5. In-plant training for sterility inspectors and laboratory technicians (according to the needs of the enterprise, professional teachers are arranged in the factory, and the whole process of operation guidance training);

Public welfare training - special training held irregularly at the request of the government, the association, and the technical committee;