Pre-evaluation

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

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

Step 2
Product analysis
Predicate

Identification of the most suitable predicate for your device.

Step 3
Requirements analysis
Requirements

Research and definition of possible tests required.

Step 4
Presentation 1
Report

Preliminary report.

Customer stage
Step 5
Customer
Gather

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

Final stage
Step 6
Gap analysis
Evaluation

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
Checklist

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

Juan Tezak
Consultant
Carlos Marín
Consultant

Are you looking for more in-depth advice regarding 510k and our services?

Contacts

Compliance 4 Devices

510k Consultants