Our work generates results
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,
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.
President and CEO,
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 and Steve Bosrock
Sr. Vice President of Operations and Vice President of Marketing ,
Torax Medical, Inc
I am very pleased with the guidance and FDA 510(k) assistance provided by DuVal & Associates for our recent Class II 510(k) clearance. We (Ambient Clinical Analytics) brought one of the first Clinical Decision Support software solutions through the FDA's 510(k) process. In addition to submitting a software medical device that the FDA had little experience with, this was also the first regulatory experience for Ambient Clinical Analytics. We received clearance 4 months post submission, a remarkable achievement we couldn't have achieved without DuVal & Associates guidance and counsel from pre-submission education on the regulatory processes, the submission package creation and reviews, and their assistance with the fast path 3rd party review process. Post submission we were assigned a new FDA reviewer, reviewing a new software medical device. DuVal & Associates provided leadership and excellent counsel on how to most effectively move through a very challenging FDA review as effectively and quickly as possible - resulting in a successful clearance for our product. I recommend DuVal & Associates to achieve the most effective and efficient path through the regulatory process.
VP Software Development,
Ambient Clinical Analytics
As a clinical stage medical device company we have worked closely with DuVal & Associates to ensure that we are operating our business with a solid foundation of compliance and business excellence in an ever changing environment.
President & CEO,
TVA Medical, Inc.
As a Dutch company, Enraf-Nonius, sells its products in over 100 countries. Despite meeting all regulatory requirements in all those countries we still found it very difficult to get market approval for any of our class 2 devices in the USA. After several unsuccessful attempts to arrange this by doing everything ourselves from the Netherlands, one of our US contacts pointed us to DuVal & Associates. DuVal reviewed our technical files, helped us finalize the 510(k) documentation and dealt with all FDA-contacts. Getting a product approved is never a quick and easy process but together we managed to get our first product approved within 8 months.For us, this was definitive proof that we have found the right partners for any regulatory question in the USA.
Chief Marketing Officer,
I have used DuVal & Associates at two start-up companies. Initially I used them to assist us with understanding the Sunshine Act. They had a complete implementation package and tools that helped us to be compliant. I have since used them on many other matters including labeling compliance, customer contracting and most recently with our strategy for an FDA submission. They are able to simplify complex concepts and hone in on areas that create risk for the company while balancing business needs. I would highly recommend them to any start-up that needs regulatory or legal advice. They are collaborative, cost-effective and if they do not have the expertise in an area, they will recommend someone who does.
DySIS Medical, Inc.
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