We develop, manufacture and sell surgical devices through our own regulatory, production and clinical channel infrastructure — in the United States and beyond.
Most device companies our size outsource everything outside their core product. We took the opposite approach: regulatory affairs, quality systems, manufacturing, industrial design, field sales and service are all in house. It is the operating model the major international manufacturers use, run at a scale where decisions still move quickly.
That structure is what lets a product go from engineering release to a hospital purchase order without passing through four different vendors — and it is what lets us support more than one product line without rebuilding the organization each time.
ISO 13485 and FDA QMSR quality systems. IEC 60601-1 electrical safety and IEC 62366 usability engineering. Design controls, risk management and post-market surveillance run as standing processes, not project work.
Every product we place carries a serial-number-level service history, a validated calibration schedule and a documented complaint pathway.
Each of these exists as a permanent internal team — not a consultant engagement.
Our own machining and assembly operation handles CNC production, sub-assembly, functional test and calibration — with design-for-manufacture work carried out alongside the engineering team rather than handed off to it.
What a partner gets is not an overseas agent. It is commercial infrastructure that is already running.
Active placements across 11 states, more than 25 hospital and ASC accounts, contracts in place with IDNs and GPOs, and a field organization split across four US regions. Products also reach Israel and the Middle East through distribution partners.
Regulatory clearance, local production, channel access and service — without setting up an entity of your own.
Learn moreTerritory reps, application specialists and service engineers across four US regions.
See open rolesHospitals, IDNs and ambulatory surgery centers, with service traceable to the serial number.
See the networkA demonstration unit for your operating room. A partnership discussion about a product line. A regulatory or service question about a device already in the field. A role on the commercial team. All of it reaches the same inbox, and it is read by people who can act on it.