Drug, Device & Food Law

Helping clients be appropriately aggressive, yet compliant. ™

Keeping you on course

We help you deal with the FDA so that you can stay focused on innovating

Reach Your Ultimate Success

Meeting with the FDA can feel like foreign territory. We will be your guide to success

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Our Services Your Success

Helping clients be appropriately aggressive, yet compliant. ™

What Clients Say?

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.

Samuel Straface, Ph.D. President & CEO Medrobotics Corporation

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.

Raul Brizuela President & CEO Argentum Medical

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.

Brian Scovil - Sr. Vice President of Operations
Steve Bosrock - Vice President of Marketing Torax Medical, Inc.
Mark DuVal

Mark DuVal

CEO & President
Lisa Pritchard

Lisa Pritchard

Regulatory, Quality & Compliance Consultant
Kathy Herzog

Kathy Herzog

Regulatory Consultant
Bryan Feldhaus

Bryan Feldhaus

Senior Attorney
Patrick Johnson

Patrick Johnson

Regulatory, Quality & Compliance Consultant
Jeff Zumhofe

Greg Spar

Software and Design Consultant
Greg Spar

Jan Dugas

Clinical Research and Clinical Compliance
Jeff Zumhofe

Scott Lambert

Engineering Design Consultant

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