Compliance 4 Devices

510k Consultants

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

Navegation

Compliance 4 Devices

510k Consultants

510k Consultants

Pre-evaluation

Service steps

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

Contacts

Navegation

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Compliance 4 Devices