Regulatory Expertise
Regulatory considerations, and the strategy surrounding them, are key aspects of any medical device development plan. SurModics has substantial knowledge and experience with the many aspects of domestic and foreign regulatory requirements. We have worked with the US FDA, CE marking entities, and the Japanese Ministry of Health, Labor and Welfare. Additionally, SurModics is one of the few companies in the industry that has regulatory experience with combination devices.
We maintain complete device master files and biocompatibility studies for all of our commercial reagents, and can show you where to find the information you need to complete submissions. Our experts can suggest what testing may be required to obtain device approval and consult on trial design.
