Most Frequently Asked Questions

Why is this portal developed?

Due to resource allocations, it is difficult for smaller companies or non-US companies to fully define 510(k) requirements. This portal intends to provide direct access to companies requiring 510(k) services, while facilitating the exchange of information.

By leveraging your knowledge about your device and streamlining the process of data gathering, we can provide better service on 510(k) submissions.

How long have you been in business? Why should we consider your services?

We have been in business since 2000 and successfully submitted more than 100 510(k) notifications since then. Please review our main website

What information should I provide?

The portal will guide you through various sections, covering the 510(k) requirements. Have your technical file around, and be ready to upload specific information. (Automation within the sections should facilitate your work).

For best use of our services, we highly recommend the user to be your quality/regulatory manager or design engineer.

How do you charge?

We will provide a quote after you fill out basic information first.

Should I just upload the technical file?

No. This portal guides you step by step to answer specific questions and attach specific files in an organized manner. If you prefer not to use this portal, please email us at to initiate a quote.

What file types can I upload?

System allows uploading pdf.

Please do NOT upload documents that are secured or password protected.

How do I receive notifications?

Notificiations are sent via email. Check often