Additional Services


Cover All Your Needs

US Agent

Specifically for the USA, we can act as a US Designated Agent for foreign companies with no local representation. We can also assist in registration and listing of devices with FDA.

Person Responsible for Regulatory Compliance” (PRRC)

We can serve as the “Person Responsible for Regulatory Compliance” (PRRC) for “micro and small enterprises” per the new European MDR requirements.

Tailor-Made Training

We can also provide customized training on-site in a variety of areas such as Quality Assurance, regulatory matters, clinical matters, etc.

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“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.”
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“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.”
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“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.”
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Our Consultants

Shoshana Friedman

Founder and Managing Director

Bosmat Friedman

Managing Director



Ready for a Consultation Call?