Medical Device Reprocessing -

 

Technical, regulatory and business startup consultation 

for the surgical practitioner and Med-Tech entrepreneur

Generate 6-figure annual savings for doctor-owned surgical practices 

  • Complete technological and business knowhow and expertise

  • Establish yourself in the lucrative and GREEN business of Single Use medical device reprocessing

  • Rapid ROI, high gross profit business, FDA-regulations limit competitive pressure

  • Offer more than 50% device cost savings to doctor-owned, office-based surgical practices (OBLs and ASCs)

About

 

We are the world class experts in Single Use Device (SUD) manufacturing/reprocessing, product engineering and development, process engineering, validation and

commissioning. We are the experts in FDA reprocessing (510K) compliance, precision micro & nanofabrication technologies, reprocessing engineering, automated process equipment systems design and engineering.

Services

 

 

We have complete plans, equipment lists, Quality System (QS) software and training regimes at the ready; we'll adapt them to your commercial site can begin working on your FDA reprocessing 510K submission(s) in less than 100 days. We're the tested start-up business experts in FDA 501K submissions/clearances, facility design, engineering, staffing, training, and commissioning, business planning, SUD reprocessing engineering, validation, optimization, and financial modeling, ROI and profitability analysis. Assistance with raising capital funding is also available. 

Projects

 

 

Successfully planned, designed, engineered and established more than 20 high technology (ISO) manufacturing facilities in the USA and abroad. Established complete Class 2 device reprocessing facilities in the USA and South Africa. Developed and cleared numerous reprocessing 510Ks on complex and challenging Class 2 medical devices.

 1(203) 615-1041

4 Research Drive, Shelton, CT