Pre-evaluation is one of the most useful tools we offer our customers for their future 510k application; it allows you to visualize and establish your own roadmap, as well as design together with us the strategy that best suits your company.

Service steps

Here’s a story line that will help you graphically understand the process.

Initial stage
Step 1 Product analysis

Classification of the device according to the CDRH database (FDA Center for devices and Radiological health)

Step 2 Product analysis

Identification of the most suitable predicate for your device.

Step 3 Requirements analysis

Research and definition of possible tests required.

Step 4 Presentation 1

Preliminary report.

Customer stage
Step 5 Customer

The customer gather the studies, analyses or tests previously done, either own or its suppliers that are available.

Final stage
Step 6 Gap analysis

Upon receipt of the documentation, it will be evaluated for the purpose of determining its acceptability by the FDA; we will establish what is pending, indicate which tests are really necessary, and which can be avoided with a comparative rationale.

Step 7 Presentation 2

We deliver a "checklist", which will serve as a tool to interact and build the final 510k file.

Juan Tezak
Carlos Marín

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Compliance 4 Devices

510k Consultants