introNAGLREITER™  has invested > $1.1M in the development of quality and business management systems:

  • ISO 13485 Certified
  • QSR Compliant
  • CAN / CSA-ISO 13485 compliant
  • Canadian Medical Devices Regulations (CMDR) compliant
  • MDD 92/43 EEC compliant
  • Stage Gate Design Control Process
  • Supports Client Company Incubation
  • Supports Multiple Product Release Types
  • SAP ERP System

quality

Quality Systems

  • Custom Quality Manual
  • Documentation Control
  • Complaint Handling
  • Control of Nonconforming Product
  • Equipment, Process and Product Validation
  • Identification and Traceability
  • Market Studies and Clinical Trials
  • Medical Device Reporting
  • Production and Manufacturing
  • Purchasing Control
  • Receiving Inspection
  • Risk Management
  • Sales Contract Review, Order Processing & Shipping
  • Tooling Control

system

Business Systems

  • Custom Business Manual
  • Custom Quality Manual
  • Asset Review and Disposition
  • Associate Lifecycle Management
  • Documentation Standards
  • Information Security
  • IT Services
  • Legal Activities
  • Project Archiving Process
  • Project Lifecycle Management