Medical Device Testing

R&D Analytical SupportIntertek’s significant expertise in bioanalysis and clinical pharmacokinetic studies allows us to support medical device companies working in the areas of preclinical and clinical drug development. Our support services include assay development for API’s, impurities, trace metals and degradants. We help determine residual solvents such as volatile organic compounds (VOCs) and organic volatile impurities (OVIs). We assess physical / chemical properties and have extensive capabilities for extractables and leachables testing - including metals, polymer components and the evaluation of packaging materials.
Material Characterization and Failure Analysis
Interaction Assessments in Combination Devices
Stability and Medical Device Testing
Regulatory, Auditing and Microbiology Services
Manufacturing Crisis and Rapid Response