TYPES OF SUPPLIERS

Category A Suppliers (Critical Suppliers)

  • Implants
  • Class IIB and Class III MDD/MDR device suppliers
  • OEM implantable devices
  • Private-label implantable devices
  • Electromechanical equipment manufacturers
  • Raw materials used for implantable devices
  • Sterile barrier packaging
  • Sterilization services
  • Analytical testing/laboratory (related to product releases)

Category B Suppliers (Standard Suppliers)

  • Class I and Class IIA MDD/MDR nonsterile device suppliers
  • Nonimplantable component suppliers, all classes
  • Raw materials used in nonimplantable devices
  • Calibration suppliers
  • Analytical testing/laboratory (related to nonproduct release)

Category C Suppliers(Noncritical)

  • Equipment maintenance/providers
  • Veterinary devices/facility services/waste management/pest control
  • Training services/staffing agencies
  • Arthrex distributors
  • Arthrex subsidiaries