Product approval of medical devices by the FDA is dependent on the FDA’s classification and product code for the device. A 510k application (premarket notification) is sufficient for class ll products. The manufacturer must demonstrate:
- The products were developed and manufactured in compliance with GMP regulations (21 CFR 820)
- The products meet the performance requirements defined by the FDA
- Analyses of the efficacy and safety (validation) were performed.
Our services include:
- Advising on document preparation and requirements
- Support in the creation or adaptation of documentation
- Building an FDA compliant quality system
- Creation of the 510(k) submission
- Submission to the FDA and support with FDA questions
The Capamed Advantage:
- Timely and competent completion of the approval process
- Efficient preparation of your application and product documentation