Medical Device R&D and Registration
Chemical Characterization of Medical Devices
- Material characterization
- Extractables study
- Qualitative and quantitative analysis of leachables
- Screening of potential raw materials
Medical Device and Drug Compatibility Study
- Extractables study
- Leachables study
- Drug method development and validation
- Drug adsorption study
In vitro degradation study of medical device
- Molecular weight and molecular weight distribution
- Weight balance
- Method development and validation for known degradation products
- Qualitative and quantitative analysis of unknown degradation products
- Observation of surface morphology
- In vitro degradation study
Biocompatibility evaluation of breathing gas pathway
- Evaluation and testing within a risk management process
- Tests for emission of particulate matter
- Tests of emission of volatile organic substances
- Inorganic gases
- Tests for leachables in condensate
- Chemical characterization of medical devices
Other Testing
Targeted leachables study
Methodology and testing for organic substances
Methodology and testing for inorganic elements
General chemical testing, such as acidity/alkalinity, evaporation residue, reducing substances, heavy metals, UV absorbance
Particulate matter testing
Ethylene oxide and ethylene chlorohydrin sterilization residues testing
Our Advantages
6000+
E&L Database
10+
Years chemical characterization experience
ISO 10993-17 and 18
Committee member
Our gold standard
Unknown Compounds are not acceptable