DESIGN &

DEVELOPMENT

Argon Medical has experience in the design, development and manufacturing of medical devices, including ISO 13485 design controls that produce a full DHF to support regulatory fillings. We also have a thorough understanding of clinical applications. This results in clinically effective, innovative solutions for our customers.

Innovation
Begins

With
Design

  • Concept refinement
  • Iterative loop testing and prototyping
  • Design confirmation
  • Design freeze/testing and documentation
  • Design for Manufacturability (DFM)
  • Characterization testing
  • Review of historical data
  • Animal and/or cadaver studies
  • Design confirmation testing
  • Product performance testing
  • Biocompatibility testing
  • Accelerated aging shelf-life testing
  • Real-time shelf-life testing
  • Packaging verification testing
  • Engineering analyses (DOE, tolerance analyses, FEA, etc.)

  • FEA
  • Reliability testing
  • Limit testing
  • Tray/pouch seal testing
  • Sterilization validation
  • Surface analysis
  • Bubble emission package testing
  • Full package conditioning/ship testing/aging
  • Limited conditioning (humidity, temperature, etc.)

Let's get Started

Learn how we can help propel your products to the next level. Contact us today for more information.

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