Our testing labs are one of the first third-party medical device testing organizations in China to obtain CNAS / CMA accreditation. We focus on the the research work of the efficacy and safety of the medical device products, and are committed to building a one-stop technical service platform for the innovation and development of medical devices. Tigermed-Jyton has also established good cooperation with all of the national testing institutions in China. We can assist our client with model testing process in China, including submitting registration testing materials, track progress and assist in dealing with technical problems.
We have professional teams and laboratories in the field of medical devices. We have a biological evaluation laboratory, a microbiology laboratory, an electrical safety laboratory, an electromagnetic compatibility laboratory, a physical and chemical laboratory, an in vitro diagnostic laboratory, and a medical software testing laboratory. The testing business covers the full life cycle of medical devices, providing key technical support for medical device developers at all stages from R&D to registration.
Registration Testing Agent
We provide testing agency services for manufacturers with stereotyped products, assist companies to select appropriate national testing labs, write product technical requirements, submit testing materials, and provide advice on many aspects such as testing protocols, timeline planning, sample delivery requirements, rectification suggestions, etc., so as to track and ensure the testing progress.
Testing Services
Our two medical device testing laboratories are located in Hangzhou and Suzhou, with 2000+ testing service item capabilities. We provide the following third-party tests:
Medical device biocompatibility testing services (based on GB / T 16886, ISO10993 series standards)
1. Cytotoxicity test
2. Irritation test & skin sensitization test
3. Hemolysis test
4. Pyrogen test
5. Acute systemic toxicity test
6. Subacute / subchronic / chronic systemic toxicity test
7. Subcutaneous / muscle implantation test
8. In vivo degradation test
9. Genotoxicity test
Animal testing studies
1. Animal efficacy studies
2. Animal pathology, toxicology research
Physical and chemical characterization of medical devices
1. Material characterization
2. Chemical routine testing
3. Extractable and leachable studies
4. Chemical equivalence studies
5. Product function performance studies
6. Medical device and packaging stability studies
7. Degradability performance studies
8. Medical device and drug compatibility studies
9. Magnetic Resonance Imaging Compatibility Study (MRI)
Microbiological testing and environmental testing of medical devices
1. Microbiological limit and sterility test
2. Bacterial endotoxin test
3. Medical device GMP production environment test
4. Purified water test
5. Biological safety cabinet, clean worktop test
6. Bacterial revert mutation test
7. Microbial barrier and antibacterial test
Disinfection control and validation of medical devices
1. Cleaning, disinfection and sterilization verification
2. Sanitize and discard date verification
Medical device aging verification
1. Shelf life verification of medical device products
2. Medical device transportation stability study
3. Packaging material expiration date study
Active medical device electrical safety testing and EMC testing
1. Safety testing of medical electrical equipment (GB9706.1 series standard)
2. Safety testing of measurement control and laboratory equipment and in vitro diagnostic equipment (GB4793 series standard)
3. Electromagnetic compatibility testing (YY 9706.102, GB / T 18268.1, GB / T 18268.26)
4. Simulation of climatic environment and mechanical environment test
5. Product pre-test and rectification verification testing
6. Usability studies
7. Risk analysis studies
8. Performance and safety evaluation of post-marketing device use
Medical software product consultation and testing
1. Testing of Software as a medical device (SaMD) and Software in a medical device (SiMD)
2. Medical device cybersecurity test
3. Quality assessment of health software
4. Individual performance tests for the quality of software products
5. Medical software usability test
6. Risk management, software development, software testing outsourcing and consulting services in the design and development stage
7. Programmable Medical Electrical Systems (PEMS) risk-related consulting services
8. Science and technology project acceptance test
9. Software product registry test
In Vitro Diagnostic Products (IVD)
1. IVD product development and design services
2. IVD product performance testing services
