ABOUT

WIn BIG with

SUD Reprocessing FDA 510K submissions and Clearances

​High-level technology & regulatory consulting services for SUD* reprocessing startups

...A proven way for the private MD practitioner 

*Single-Use Medical Device

to grow a practice's bottom line

About Our Company

We're respected worldwide as experts in high-technology manufacturing engineering, new product development, and have 15 years of experience in Medtech,  single-use medical/surgical device reprocessing. Our focus is on FDA (510K) creation, submission and regulatory compliance. We're experts in precision micro and nano- fabrication technology, precision metallurgy technology, med device reprocessing engineering, novel reprocessing equipment system design & engineering, micro-fab process engineering, and in domestic and international technology business startup and development.

 1(203) 615-1041

4 Research Drive, Shelton, CT