Medical Device R&D and Registration
Medical Device Chemical Characterization – ISO 10993
- Extractables study
- Leachables qualitative and quantitative analysis
- Chemical equivalence study
- Material characterization
- Screening of raw materials
Medical Device Leachables Study
- Selection of known leachables
- Method development and validation
- Simulated clinical chemical release study
Medical Device and Drug Compatibility Study
- Leachables study- known and unknown
- Drug method development and validation
- Drug adsorption study
- Insoluble particulate test
Gas Pathway Device Biocompatibility Study – ISO 18562
- 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
Medical Device In Vitro Degradation Study
- Molecular weight and molecular weight distribution
- Weight balance
- Degradation products method development and validation
- Degradation products qualitative and quantitative analysis
- Observation of surface morphology
- In vitro degradation study
Additional Chemistry Testing Services
Method validation and testing for organic substances and inorganic elements
General analytical chemistry testing, such as acidity/alkalinity, evaporation residue, burning residue, reducing substances, heavy metals, chlorides, turbidity and color, UV absorbance, Fourier
Transform Infrared (FTIR) Scanning
Ethylene oxide and ethylene chlorohydrin sterilization residues testing
Solvent residue testing
Particulate matter testing
Our Advantages
6000+ E&L Database
Access to a 6,000+ material extractables database, enabling comprehensive and accurate extractables and leachables testing.
10+ Years Experience
Over 10 years delivering reliable chemical characterization data for medical device R&D and regulatory submissions.
ISO 10993 Committee Member
Active member of ISO 10993-17/18 committees, delivering regulatory-aligned chemical testing for medical devices.
Strict Compound Control
Strict quality control ensures all compounds are identified, guaranteeing safe and compliant chemical characterization.