Customer Success Stories

Success Stories

Hear from our recent clients

“Working with ProMedoss has been tremendous for Aqua Medical! They have everything we could ask for in regulatory consultants: deep regulatory expertise, not just the theory, they know what works! They help develop strategic options, they’re great at risk assessment, they have a huge bias for action, they know what needs to be done, they move at the fast speed of a startup and they have strong relationships at the FDA. And of course they deliver results! ProMedoss secured three 510(k)s for us in record time! We continue to work with them because we’re staying with what works!”

Lloyd Mencinger

President & CEO Aqua Medical

“As a medical device start-up, one of the most critical decisions we faced was defining our regulatory strategy in the early days. It is a decision that ultimately shapes the horizon of the company. We were fortunate to have ProMedoss guide us through this process.We have been working with ProMedoss for the past six years, and during that time, we have benefited immensely from their regulatory wisdom and expertise. With their support, we were able to achieve the “desired” FDA approval, a significant milestone for our company.Shosh and Bosmat’s expertise ranges from regulatory strategy to the finer details of regulatory submissions. Throughout the process, they have consistently demonstrated accuracy, communication, and cost-effectiveness, making our collaboration seamless and efficient.As the CEO and CTO of Virility Medical Ltd, we are confident that our collaboration with ProMedoss will continue to be fruitful in the future.We highly recommend ProMedoss to any medical device start-up seeking regulatory guidance and expertise.”

David Salton

CEO & Tal Gollan Founder and CTO, Virility Medical Ltd.

“I have been working with Bosmat and Shosh for several years from project initiation to successful FDA clearance. They are high performers with fast reaction time, are familiar with the smallest details of the project and are always ready to assist. I consider them one of my best subcontractors as they provide top level service with a professional attitude and a smile.”

Stav Tori

CEO, ARK Surgical

“The biggest benefit of working with ProMedoss is that you get the information that you have asked for without the “fluff” you get from so many other consultant firms. Working with ProMedoss on multiple projects and challenges, the regulatory services and information are accurate, complete, and to the point. They are efficient in providing us with ways how to navigate the modern complex regulatory biotech landscape. Shosh and Bosmat’s regulatory expertise and insights help us find the solution that works best for our products and processes.”

Manfred Abel

Quality System & Regulatory Affairs Manager, Greiner
Bio-One North America, Inc.

“ProMedoss has recently assisted us in submitting a 510(k) for extending the intended use of our cleared device. The regulatory review was smooth, ending with a new clearance within the usual timeframe. We thank ProMedoss for their professional and experienced guidance.”

Yoel Bergman

QA/RA Director & Yoav Venkert CEO, Hospitech Respiration Ltd.

“I have been working with ProMedoss for the last 5 years using their services for various FDA related submissions as well as Quality related matters. ProMedoss assisted us with an initial pre-sub interaction for our novel stent system and have successfully secured three 510(k)’s for our various EndoGI Biliary Stent Systems”

Omri Naveh

CEO, EndoGI Medical

“I worked with Shosh Friedman in 3 companies, three different technologies, with multiple submissions. Together we achieved important precedents with the FDA, getting clearances and labels that people thought were impossible without PMA and extensive clinical trials. Shosh is very knowledgeable and experienced, as well as pragmatic, she understands the business objectives and what’s needed to market the product, while keeping customer in full compliance. For any future registration needs in the US or Europe, Shosh is my go-to expert.”

Yoram Ashery

CEO, Nostromo Energy