Beijing Tigermed-Jyton Co., LTD. ——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