510K Medical Device Premarket notification submissions

Get an ACCURATE and QUICK quote and GAP ANALYSIS for your medical device FDA clearance

Our website is an efficient electronic platform allowing you to fill out and upload your medical device information in an organized manner, helping us provide you with a regulatory gap analysis at a nominal fee. In the same time, we will quote you on the 510k based on current status of your documents. We will walk you through the process and help you narrow down all the information needed for your 510k submission, therefore streamlining the submission process and reducing the applicable consulting fees.

Our website links to FDA databases - which will be reflected within the screens as you fill out certain information. You’ll receive our regulatory report shortly after you complete the data entry.

The nominal fee paid toward the regulatory report will be credited back to you with the 510k submission contract. You will not pay twice for the same work we perform during the first step.

Please help us in providing good quality data. The quality of the data you enter impacts the quality of our regulatory report as well as the 510k quote. Help information is provided throughout the process.

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