Medical Device
Design, Prototyping,
& Testing
Materials & Bioengineering

image: High-throughput cancer screening device

High-throughput cancer screening device

 
image: Multi-fiber Raman spectroscopy-based diagnostic system

Multi-fiber raman spectroscopy-based diagnostic system

 
image: Blood testing

Blood testing

 
image: Instrument evaluation

Instrument evaluation

Since 1978, Southwest Research Institute (SwRI) has designed, prototyped, and tested medical devices for the healthcare industry. SwRI offers clients a multidisciplinary approach to problem solving and a significant resource for complete medical device development.

SwRI uses a proven, quality-based development process to transform product concepts into reality. SwRI's medical device development follows the quality system that is ISO 13485:2003 certified and compliant with the FDA Quality System Regulation. SwRI engineers and scientists are experienced in developing high-quality documentation necessary for FDA 510(k), PMA, and EU submission.

Medical Device

  • Design and Prototyping
    • Materials
    • Electrical
    • Mechanical
    • Optical
    • Software
  • Applications
    • Tissue engineering
    • In vitro diagnostics
    • Point-of-care device
    • Perfusion system

Testing and Evaluation of Medical Devices

  • Mechanical testing
    • Tension and compression
    • Shear/torsion/fatigue
    • Wear debris
    • Creep/vibration/shock
  • Environmental testing
    • Corrosion/salt/fog/UV exposure
    • Temperature/humidity/pressure
    • Thermal shock/stability
    • Flammability
  • Material/chemical testing
    • Chemical analyses
    • (GC, MS, HPLC, NMR, FTIR, LC, RID, X-ray diffraction, etc.)
    • Extractable/leachable
    • Spectroscopy
    • Viscosity
  • Biological testing
    • Biocompatibility
    • Antimicrobility

Related Terminology

adaptive materials  •  autonomic materials  •  hybrid materials  •  nanomaterials  •  materials testing  •  materials characterization  •  electrophoretic deposition  •  biomaterial  •  medical device  •  biosensors  •  chlorine dioxide  •  nanoparticles  •  encapsulation  •  drug delivery  •  control release  •  tissue engineering  •  regenerative medicine  •  wound care  •  wound dressing  •  surface coating  •  scaffolds  •  bioreactor  •  perfusion system  •  ISO 13485

Benefiting government, industry and the public through innovative science and technology
Southwest Research Institute® (SwRI®), headquartered in San Antonio, Texas, is a multidisciplinary, independent, nonprofit, applied engineering and physical sciences research and development organization with 10 technical divisions.
04/15/14