Device Master Files. Drug Master Files. Technical Support Files. REACH. TSCA. Count on our highly experienced regulatory team to provide information on our coatings that will accelerate your device approval in the US, Europe, China and Japan.
As you move through the device development stages, regulatory considerations can be a source of concern. Surmodics is at your side, anticipating issues and providing hands-on support to help you fulfill national and international requirements. This includes working with you as you interact with the FDA, CE, Japanese Ministry of Health, Labor and Welfare, and other governing bodies.
Rely on Surmodics for efficient help in providing and finding the information you need to complete submissions. We maintain complete Master Files and biocompatibility studies for all of our commercial reagents.
Our experts can also discuss if preclinical testing may be required to obtain device approval and consult on clinical trial design.
“One of the things that’s really important to us (and that Surmodics is great about) is supporting our regulatory submissions processes. The fact that they have that master file and their coatings have been through a regulatory review before is pretty powerful information.”
– 2011 customer statement on file at Surmodics