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Extractables and Leachables Medical Device Testing
Cambridge Polymer Group provides support to regulatory strategies for ensuring the biological safety of new and existing medical devices.
By understanding the types of extractables and leachables present in a medical device, manufacturers can mitigate potential risks associated with biocompatibility and device performance. Regulatory bodies like the FDA mandate E/L testing for medical devices to ensure patient safety.
Why Is Chemical Characterization Important for Medical Devices?
Chemical characterization is a crucial step in the medical device development process. It helps identify and quantify the chemical composition of a device’s materials.
We offer a comprehensive E/L testing workflow tailored to your specific medical device. Learn more about our extractables and leachables ISO 10993 part 18 testing
ISO 17025 Accredited #3930.01
“CPG is absolutely the leading lab in the country for polymer testing. They don’t just offer these tests–they’ve developed the procedures, worked with key partners, created the test, and validated the quality throughout.”
Lab Manager,
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