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
-
Product & Process Development
-
Design Verification
-
Test Method Development
- 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.
