At NAGLREITER™ MDDO, we offer a wide array of systems to support medical device companies of any size at any stage. Our model utilizes fractional Access & Use to best-in-class systems for optimal Medical Device Development, Manufacturing and Distribution. The result is optimal systems utilization deployed when the company or project requires it, which improves time to market without the risk of heavy fixed costs. NAGLREITER™ MDDO associates are trained to our FDA and ISO compliant Quality System and Business Systems.


introNAGLREITER™  has invested > $1.3M in the development of quality and business management systems:

  • ISO 13485 Certified
  • QSR Compliant
  • MDD 92/43 EEC compliant
  • Stage Gate Design Control Process
  • Supports Client Company Incubation
  • Supports Multiple Product Release Types
  • QT9 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