We will not make a submission or have any type of communication with the FDA without first getting Mark DuVal’s insights and recommendations. His understanding of FDA policy and all its nuances, and even more importantly, his personal relationships with the senior folks at the FDA make him an indispensable member of our extended regulatory team. As a member of the Medrobotics executive team and Board of Directors, I cannot think of a better way to mitigate regulatory risks than to include Mark DuVal and his team in all major regulatory decisions and actions involving the FDA.

We've used DuVal & Associates to help us make five 510(k) submissions. What we like about them is their great relationship with FDA and their advocacy for us. They know how to work with the Agency and help communicate why our device belongs on the 510(k) path and then help us move it along expeditiously to clearance. They've taught us a 510(k) submission is more than cutting and pasting together data in a framework. It is an advocacy document where you tell your story about the elements of the 510(k) program so you don't end up with a de novo or PMA. It's also about giving FDA the right amount of data and pushing back diplomatically when the demands are too great. We have enjoyed our relationship with the firm, the practicality of their work and their responsiveness to our needs and passion for our success.

Torax Medical has used DuVal & Associates for a variety of our Regulatory and Compliance needs. From Compliance Documents and Training, HCP reporting, interfacing with FDA, review of Labeling and Marketing literature, DuVal & Associates provides excellent guidance and support. We really appreciate their experience, hands-on practical approach, and timely responses to all of our business needs.