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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