ENGINEERS & QUALITY EXPERTS

IN MEDICAL DEVICE

  • COMPONENT DESIGN, REVIEW, AND VENDOR COLLABORATION
  • FINISHED DEVICE DESIGN, DESIGN VERIFICATION TESTING
  • QUALITY MANAGEMENT SYSTEM CONSULTING, 510K SERVICES

Our
Services

  • Device Design

    Device Design

    Let’s take your concept and make it reality; or refine your prototype into a marketable product ready to sell. We also offer assistance with design verification testing and test fixture/method development.

  • 510k

    510k Consulting

    Navigate the FDA 510k process with help from professionals that have authored successful approvals.

  • Custom Additions icon

    Plastic Components

    Injection molding design consulting. Mold flow analysis, chemical compatibility testing.

  • QMS

    Quality Management System Development

    Electronic QMS set-up and launch. Data Migration, Process development and improvement.

GET IN TOUCH

What Our Clients Say:

  • High level of attention to detail, keeps service/production in mind throughout design.

  • Helped us set-up and launch our Propel QMS from scratch.