We are a consulting company led by experienced professionals focusing on guiding you through the elaboration of pre-marketing notification (510k).
We provide you with personalized and direct attention. We work hand in hand with our customers in the search for a common goal,
SUCCESS
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.
To guide your product through the most adequate path in order to avoid surprises and unnecessary costs.
Assistance registering your company with the FDA, developing your product, adapting the quality control system and preparing for possible FDA audits.