Expertise

ConceptDesign & DevelopmentVerification and ValidationRegulatoryQMSProduct Launch

Areas of Expertise

  • Neuro/Spine
  • Orthopedics
  • Urology
  • General Surgery
  • Ophthalmology
  • Dental
  • Mobile Health Applications

Our Capabilities

  • Concept Generation
  • 2D/3D CAD Modeling
  • Design for Manufacturability
  • Engineering Analysis – FEA
  • Material Selection
  • Rapid Prototyping (3D Printing)
  • Metals, Polymers
  • Risk Assessment
  • Sterilization

 

 

  • Mechanical Testing
  • Regulatory Pathway
  • 510(k)s
  • Post-launch Regulatory Support
  • Compliance Auditing
  • 21 CFR 820
  • ISO13485, ISO 9001
  • UDI (Unique Device Identification)

Project Experience

Spine

  • Cervical Plates and Screws
  • Interbody Fusion Devices
  • Motion Preservation Systems
  • Posterior Cervical Hook and Rod System
  • Minimally Invasive Pedicle System
  • Facet Screw System
  • Laminoplasty Plate System
  • Interspinous Process Spacer System
  • Spine Fusion Sensor System

Ophthalmology

  • Glaucoma Stent
  • Eye Speculum

Dental

  • Dental Implant System
  • Dental Cleaning System

Orthopaedics

  • Total Hip Arthroplasty System
  • Total Knee Arthroplasty System
  • Limb Salvage Reconstruction Devices
  • Patient Specific Implants
  • Clavicular Fracture Plate System
  • Trauma Plates and Screw Systems

Urology

  • Ureteral Dilators
  • Ureteral Stents
  • Urinary Catheters

General Surgery

  • Digital Endoscope System
  • Biliary Stents
  • Biopsy Needle
  • Laparoscopic Port Closure Device

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