Beijing Tigermed-Jyton Co., LTD. ——GMP System Counseling

According to the requirements of the "Good Manufacturing Practice for Medical Devices", enterprises shall establish a quality management system suitable for the manufacturing and running of the medical devices and ensure their effective operation. Regarding the risk of medical devices, in order to manufacture safe, effective and quality standard compliant products, it is necessary to establish a set of quality systems based on hardware, supported by file system, and guaranteed by personnel, ensuring a systematic, coordinated and effective operation. We provide the following services: 1. Assessment of the existing systems and compliance gap analysis 2. Clean plant establishment and validation guidance 3. Common facilities verification counseling 4. Special process confirmation counseling 5. Design and development process support 6. Counseling / preparation / revision and improvement of quality system documents 7. Training and assessment of quality system personnel 8. Quality system manufacture workshop, manufacture equipment and other hardware compliance review 9. Quality system related regulations and knowledge training 10. Guide / accompany internal inspection / management review; 11. Medical device GMP system simulation assessment 12. Preparation, submission, tracking of quality system assessment materials until the inspection report is obtained 13. Writing / counseling of annual self-inspection report of medical device quality management system 14. Medical device product risk management periodic report writing / counseling 15. Quality management system improvement / rectification consultation