Welcome to our Premarket Submission File Compilation Service, where we specialize in expertly preparing and compiling submission files for both Premarket Notification 510(k) and Premarket Approval (PMA) applications. Our service is designed to streamline the complex and often daunting process of FDA submission for medical device manufacturers seeking market entry in the United States.
Our 510(k) submission service focuses on assisting clients in demonstrating that their medical device is as safe and effective as a legally marketed device (predicate device) and does not require PMA. Our service includes:
Our PMA service is tailored for devices that represent a breakthrough in new technologies or for devices that cannot be cleared through the 510(k) process. This service includes:
We support in setting up a compliant and robust submission file that fulfills all requirements. You have already a submission file but needs an update?
We are here to help.
You have difficulties to identify which format is suitable for your product? You are not sure if your current documentation is sufficient?
Leave it with us. Our experts will guide step by step.
Your product is already on the market. Do you know which post market requirements need to be met? Don’t worry. We support with the proper planning and define the most appropriate post market reporting. This ensures your submission file will stay up-to-date.
