Robert Stathopulos

Greater New York City Area United States

Early Stage R&D Executive -- Medical Device and Drug-Device

Medical / Health Care / Pharmaceuticals

We consult to early stage ventures in design, development and manufacture of novel medical device and combination products. Our roles include management advisor, due diligence reviewer, technical project manager, or interim director of engineering or operations. We specialize in design controls compliance, product development procedures, design history file compilation, tracing design specifications to user requirements, selecting and managing the contract manufacturer, creating a reliable supply chain, estimating clinical and commercial product costs, and reducing design and manufacturing risks.