learn what our clients say about us:
Chief Technology Officer, Midsize Medical Device Company
"Working with Omnee Strategic Solutions has been fitting for our company, the young OEM spine device manufacturer. Their expertise in Regulatory Affairs is unparalleled which they drive from many big medical device company experience they have, essentially eliminating the need for our in-house RA department. With Omnee Strategic Solutions guidance, we successfully navigated four FDA 510(k) submissions in the past two years, even challenging the FDA’s perspective and steering them to see through the lens of product developers. Their ability to think with us, and articulate complex product details and regulatory insights into successful submissions has been nothing but pleasant and invaluable."
Chief Executive Officer, Medical Device Start-up
'Working with Omnee Strategic Solutions has been a pleasure. Finding a regulatory professional that is both knowledgeable and business savy is rare. Omnee Strategic Solutions understands how to complete the task at hand in an efficient manner while ensuring that the regulatory requirements are completely met. I have previously worked with over a dozen FDA consultants and none had the regulatory knowledge combined and business acumen that Omnee Strategic Solutions possesses. Under Omnee Strategic Solutions direction and guidance, Enamel Pure received its FDA 510(k) clearance in 3 months and 1 day, which is a remarkable result, while keeping the cost reasonable. We are now working with Omnee Strategic Solutions on further indications and our in-house quality system. Omnee Strategic Solutions offers complete supervision of the FDA process in a cost effective and professional manner, and we could not be more pleased with their services"
Vice President R&D, Midsize Medical Device Company
"Partnering with Omnee Strategic Solutions has been instrumental in our journey towards regulatory compliance and achieving excellence in quality assurance. Their team's in-depth knowledge and proactive strategies have provided us with invaluable support in navigating complex regulatory landscapes. Thanks to their strategic guidance and meticulous attention to detail, we've accelerated product approvals and maintained strict adherence to industry standards. We highly recommend Omnee Strategic Solutions for their professionalism, expertise, and steadfast dedication to our success."
Chief Executive Officer, Medical Device Start-up
"Navigating my way through the FDA application maze is an insurmountable task, something I not only had no idea as to where to begin or frankly had time for. Omnee Strategic Solutions, was able to navigate through this complicated process with ease and completed my task to get me up and running in quick order. I could have never done it without them!"
Senior Manager, Regulatory Affairs - Large Medical Device Company
"As a client of Omnee Strategic Solutions, I highly recommend their services to help navigate medical device compliance. This firm is knowledgable on US FDA and EU MDR requirements, and has driven excellent results through many regulatory challenges. Regulatory professionals tend to seek resources that can demonstrate current involvement with many regional registration laws; especially when regions are constantly revising regulations. Medical device knowledge of quality system requirements is also very, important. I choose to partner with a group that possesses these strengths. Omnee Strategic Solutions is just that organization. They drives results and have helped me successfully cross many finish lines!"