We specialize in creation and execution of device verification and performance testing plans to support developments and regulatory submissions. Testing is performed according to ISO, EN, DIN, ASTM and applicable regulatory standards, including FDA requirements (e.g., 510(k) submissions, IDE applications, etc.). The majority of tests are performed in-house. For selected laboratory tests, such as biocompatibility, sterility, particulates, conditioning (e.g., aging, environmental, transport, etc.), and package integrity, CMI collaborates with external partners.