Our Model

We encourage you to start with the regulatory evaluation step, followed by the 510(k) submission. This would give you the breathing space to gather missing data or upgrade documents before committing to the 510(k) submission.

Step 1 is to evaluate your device and your technical data.

If you have basic technical data available, you can start right now by paying via credit card and proceeding into the portal secure area, where you will answer questions and upload documents. We will evaluate and provide regulatory report that includes gap analysis, strategic planning and other regulatory information, including but not limited to:

     1- Regulatory classification
     2- Predicate device
     3- Applicable guidance documents
     4- Applicable recognized standards
     5- Labeling review
     6- Substantial equivalence review

Step 2 is the actual preparation of the 510(k). If you decide to move forward with the 510(k) submission, your fee toward the regulatory evaluation will be fully credited back to you.

We are committed to your success, and will follow diligently with FDA to obtain your clearance letter.