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


E&L Database


Years chemical characterization experience

ISO 10993-17 and 18

Committee member

Our gold standard

Unknown Compounds are not acceptable

To learn more about medical machinery testing, please contact us