Capabilities

Six in-house functions behind every product we place.

Each is a permanent internal team with its own leadership, procedures and records. Together they cover the full path from engineering release to recurring hospital revenue.

01

Regulatory & Market Access

Regulatory Affairs
  • FDA 510(k) submissions and Pre-Submission meetings
  • Establishment registration, device listing, UDI-GUDID
  • MDR adverse event reporting, recalls and complaint handling
02

Quality Systems & Testing

QMS & Validation
  • ISO 13485 and FDA QMSR quality system build and maintenance
  • IEC 60601-1 / -1-2 electrical safety and EMC
  • ISO 10993 biocompatibility, sterilization and packaging validation
03

Local Manufacturing

Production
  • In-house machining centre: CNC, assembly, test and calibration
  • Technology transfer, DFM redesign and supplier qualification
  • Domestic production that insulates tariff and supply-chain exposure
04

Industrial Design & Engineering

Product Development
  • Enclosure and human-factors redesign for local clinical practice
  • English-language GUI and IEC 62366 usability engineering
  • Electrical, mechanical and software teams with shared platform modules
05

Channel & Clinical

Commercial
  • Direct access to an existing hospital and ASC network across 11 states
  • KOL relationships, cadaver lab training and case coverage
  • Society meetings, trade shows and English clinical literature
06

Shared Services

Operations
  • One team serving multiple product lines, with fixed cost spread across them
  • Customer service, spare parts, logistics and field service scheduling
  • Finance, compliance, insurance and product liability under one roof

One quality system. Multiple product lines. Multiple markets.

Machining, assembly, functional test and calibration run under a single documented system. Technology transfer and design-for-manufacture work are done by the same engineers who support the product in the field, which is what keeps a design change from becoming a six-month round trip.

Clinical footprint

Specialties where our technology is already in use.

Solid outlines mark specialties with clinical use and an installed base. Dashed outlines are development directions.

Surgical Oncology Thyroid ENT / Head & Neck Breast Hip & Knee General Surgery GI / Bronchoscopy Neurosurgery Urology Spine / Trauma Dermatology

Product categories carried through this channel include surgical instruments, energy and electrosurgical consoles, plasma ablation systems, endoscopic probes, surgical robotics and recurring high-value disposables.

Commercial models

Five structures, all of them in active use.

01

Consignment PlacementPrimary model

The hospital carries no capital cost. The console is placed on site and revenue is earned through recurring high-value disposables. This accounts for the largest share of our installed base.

02

Capital PurchaseCapital budget

The hospital purchases the console through its capital budget, with a long-term disposables supply agreement and annual service coverage.

03

Limited ConsignmentTransitional

A bridge structure with an agreed volume threshold, used while a new account ramps up.

04

Demo & TrialEvaluation

Demonstration and loaner units enter the hospital evaluation process and convert into permanent placements.

05

International DistributionExport

US regulatory clearance and clinical data support entry into Israel and the Middle East through distribution partners.