Medical Device Testing
Analytical Testing for Medical Device Manufacturers
Impact Analytical provides contract testing services to the Medical Device Industry. We specialize in testing support for class I, II, and III devices and test everything from raw materials to the finished device. All medical devices that need to be tested must follow appropriate regulatory processes, according to the country the device is marketed in. We are compliant with all industry requirements and regulations so testing will meet your needs whether it's FDA guidelines, ASTM methods, CE regulations, ISO quality standards, or cGMP and GLP guidelines. We provide analytical support throughout the product life cycle of your device.
Medical Device Testing Services
- Leachable and Extractables
- Failure Analysis
- Material Characterization
- Contaminant Identification
- Raw Material Characterization
- Lifetime Product Stability
We have a rigorous quality program in place and have the experience and capabilities to work with all types of polymeric materials.