Contract Manufacturing

From first engineering build, through qualification/ validation, production, distribution and service.

Klugē Design provides contract manufacturing from first engineering build, through qualification and validation, production, distribution and service. KDI evaluates the manufacturability of a product with an engineering build and suggests areas of improvement. We foster an open communication environment and are known for immediately responding and personally addressing client questions.

  • Prototype, Qualification and Pilot builds
  • Manufacturing Engineering
    • Assembly & Test equipment design
  • Low to high volume capability
  • Comprehensive ERP System
    • Fully integrated MRP
    • Capacity Planning
    • Inventory Management
    • Lot Control
  • Assembly of complex, precision electro-mechanical devices
  • Supplier and Tooling Management
  • FDA GMP Compliant, ISO:13485:2003 and ISO:9001:2008
    • Class I and Class II Medical Devices
    • Effective Quality Management System
    • Build and maintain Device History Record
  • Regulatory Compliance
    • UL/ CSA/ CE Mark
  • FMEA Studies
  • Depot Service Capabilities
  • Warehouse and Distribution Services

We expect KDI to take a major assembly and design it for manufacture. They play an important role in suggesting improvements. We get support on designing for manufacture, if needed. They are very diligent in letting us know if a part poses a manufacturing issue.

Things change a lot with new products and sometimes at the last minute; not everyone can “turn on a dime” like KDI does. Our bigger contract manufacturers don’t react to our needs like KDI does.

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