Medical Device R&D and Registration
Chemical Characterization of Medical Devices
- Material characterization
- Extractables study
- Qualitative and quantitative analysis of leachables
- Chemical equivalence study
Medical Device and Drug Compatibility Study
- Extractables study
- Leachables study
- Drug method development and validation
- Drug adsorption study
Degradable Medical Device Research
- Molecular Weight Testing (GPC)
- Mass Balance Testing
- Qualitative analysis of Degradation Products
- Method Development and Validation of Degradation Products
- Quantitative analysis of Degradation Products
Other Testing
General chemistry tests: pH value, evaporation residue, reducing substances, heavy metals, UV absorbance
Method development validation and testing of target compounds
ISO18562 Biocompatibility Testing of Gas Pathway
Ethylene Oxide Residual Testing
Our Advantages
4500+
E&L Database
10+
Years chemical characterization experience
ISO 10993-17 and 18
Committee member
Our gold standard
Unknown Compounds are not acceptable