Third-party Testing of Medical Devices

Certified third-party medical device and pharmaceutical testing institutions

Testing Platform

About D.T.

D.T., has long been dedicated to testing and risk assessment for medical devices (including raw materials, packaging materials, and final products). We provide one-stop services encompassing physicochemical testing, product efficacy evaluation, biosafety assessment, product degradation and degradation product analysis, simulated transport and shelf-life validation for packaging, as well as domestic and international registration consulting services.

We hold certifications including ANAB GLP, OECD GLP, and CNAS GLP, enabling us to meet registration requirements for FDA, CE, NMPA, and other regulatory bodies.

Testing Services

Medical Device and Pharmaceutical Testing and Evaluation

Biocompatibility

Cytotoxicity, irritation, sensitization, local post-implantation reactions, blood compatibility, genotoxicity...

Chemical Characterization

Chemical properties testing, qualitative/quantitative analysis, residue testing...

Packaging Validation

Accelerated aging, transport simulation, seal integrity, seal strength...

Microbial Testing

Sterility testing, sterilization validation, bioburden testing, bacterial endotoxins...

Preclinical Safety and Efficacy

Experimental protocol design, model establishment, surgical implementation, statistical analysis...

Others

Drug testing (allergy, pyrogen, abnormal toxicity), customized testing services

Qualifications and Certificates

Covering the United States, OECD countries, and China with GLP certification, test results are recognized in over 150 countries and regions worldwide.