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.