Experts in
510k

We are a consulting company led by experienced professionals focus on guiding you through the elaboration of pre-marketing notification (510k).

Welcome to Compliance 4 Devices

Family operated organization

We provide you with personalized and direct attention. We work hand in hand with our customers in the search for a common goal,
SUCCESS

Specializing in small businesses

Our focus is on small businesses and entrepreneurs; we understand the importance of having a team that is able to think “outside the box” in order to evaluate and offer all possible alternatives.

Our mission

To guide your product through the most adequate path in order to avoid surprises and unnecessary costs.

Make sure you are in the right hands when you apply for a 510k.

Other services

In addition to the 510k service we can also offer:

Assistance registering your company with the FDA, developing your product, adapting the quality control system and preparing for possible FDA audits.

Projects under development

New
Electrocardiograph

Mexico

June- 2021

Introduction of a 510k for a new electrocardiogram. We are currently preparing the application to be filed with the FDA.

New Feminine
Moisturizing Gel

USA

July- 2021

Introduction of a 510k for a new feminine moisturizing gel.  We are currently preparing the application to be filed with the FDA.

New
Patient Monitor

Mexico

August - 2021

Introduction of a 510k for a new movile diagnostic center. We are currently preparing the application to be filed with the FDA.

Contacts

Compliance 4 Devices

510k Consultants