Solutions for Success
Our extensive knowledge in the regulatory and business fields and our vast experience working within the medical device field provides our team with the ability to objectively assess the feasibility and profitability of medical device companies and novel technologies.
Whether you are an individual or a firm looking to merge, acquire or invest in a company or novel technology, we will conduct an in-depth audit and analyze the current status of the market and regulatory environment in an effort to minimize any potential risk to your investment.
“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.”
“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.”
“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.”
Founder and Managing Director