Tigermed-Jyton has a senior expert team with nearly 20 years of experience in the field of medical device GMP. The team has participated in the regulation amendment discussions organized by NMPA for multiple times, and participated in the drafting and amending multiple regional medical device regulations. We have strong capabilities to comprehensively analyze, judge and handle compliance affairs for medical device companies. We can provide professional guidance and assistance for customers to establish and maintain quality management systems, legally and reasonably avoid policy risks, and carry out risk control management.
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
MAH Counseling
MAH policy has effectively resolved the practical challenges faced by tech startups and research institutions in bringing their product to the market. It has addressed issues such as idle resources, manufacture facilities and equipment as well as insufficient work volume for skilled manufacturing personnel before their products’ marketization. Additionally, it prevents wastage of resources resulting from discrepancies between pre-market samples and post-market manufacturing, which includes the excessive utilization of funds before marketing and the extended recruitment of specialized personnel at various stages of manufacture.
We provide the following related services:
1. Prompt dissemination of related regulations from various regions to ensure keeping up with the latest policy information
2. MAH mode planning, binding the 2 sets of supporting systems for R&D and manufacturing trustee
3. Trustee’s system evaluation to help license holder find suitable manufacturers
4. Establish quality systems and risk systems to provide the most reliable support for product marketing application
5. Simulation inspections of medical device GMP (Good Manufacturing Practice) to ensure a smooth inspection process for license holder
6. Supplier recommendation, covering from trustee manufacturers to product testing and raw material recommendation
7. System personnel training and assessment
GSP System Counseling
Medical device distributors should comply with the requirements of regulations such as the “Good Service Practice of Medical Device”. Our GSP compliance related consulting services include:
1. Collection and dissemination of medical device operation regulations
2. Establishment of management GSP system and personnel training
3. Business management software recommendation
4. Evaluation and selection of third-party distribution agencies
5. Business license data collection / application
6. Business management data analysis, statistics, application
Related Services
1. Consulting services to assist the manufacture site meeting the requirements;
2. Consulting services to assist manufacture and testing equipment meeting requirements;
3. Consulting services for the establishment of the team;
4. Technical consulting services related to product trial production;
5. Risk assessment and management services for trial production process;
6. Consulting services for batch production and batch records;
7. Consulting services for product manufacture process validation;
8. GMP / GSP / GCP system document consulting services;
9. Assist in the application of Class II and III medical device manufacture licenses.
