Medical Device Clearances

Through Cambridge Polymer Group’s extensive experience with material development, FDA submissions and root-cause-analysis, we can provide value throughout the product lifecycle.  In particular, we have frequently provided assistance to clients during FDA submissions, whether in an advisory role, or providing analytical testing and interpretation.  We have assisted clients with 510K clearance, recommending and conducting a suitable set of tests, and providing detailed reports for FDA scrutiny. We also serve on multiple ASTM committees for medical device analysis, and hence are familiar with the potential new testing requirements as they are generated.  All of our testing is conducted under our ISO 9001:2015 quality management system.