Testing and Evaluation of Medical Devices 

Southwest Research Institute® (SwRI®) is an independent, nonprofit, applied research and development organization dedicated to technology support, development and transfer for clients worldwide. SwRI has the facilities and expertise to fully test and characterize medical devices and combination products.

With more than 3,000 technical and support staff, SwRI can assemble a multidisciplinary team to evaluate all technical aspects of a medical product. In addition, experienced staff members are available to assist in solving design and development problems that may be discovered during the evaluation process. Projects are managed with the understanding that time to market is critical.

The Bioengineering Section 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 510K, PMA, and EU submissions.

Medical Product Evaluation Functions

• Verification planning using risk management techniques
• Protocol development
• Custom fixture development
• Testing according to published standards, client protocols and custom protocols
• Design analysis and review
• Finite element analysis
• Test reports with data, analysis and photos
• In-process test development
• Failure analysis
• Design verification (complete test package)

  Mechanical Testing Capabilities

• Tension and compression
• Shear / torsion / fatigue
• Wear debris
• Creep / vibration / shock
• Hardness / drop
• Micromechanics

Environmental Testing Capabilities

• Corrosion
• Salt / fog / UV exposure
• Temperature / humidity / pressure
• Altitude
• Thermal shock / stability
• Accelerated aging
• EMC / EMI
• Electrical safety
• Radiation
• Flammability
• Noise

Materials/Chemistry Testing Capabilities

• Organic chemical analyses (GC, MS, HPLC, NMR, FTIR, LC, RID)
• Inorganic chemical analyses (IC, XRF, AA, X-ray diffraction, ICPAES, ICPMS, laser ablation ICPMS, wet classicial chemistry)
• Extractables / leachables Metallography
• Trace metal analysis / structural analysis / particulate analysis
• Raman spectroscopy
• Viscosity

Other Testing Services

• Coordination of animal trials and clinical studies
• Product software verification
• Toxicity
• Leak / drip
• Biocompatibility
• In vitro simulation

SwRI maintains an open-area test site to measure radiation emissions from electronic and electrical equipment. The level test site is clear of electromagnetic reflecting surfaces for a minimum radius of 32 meters. Three-phase 60 and 400 Hz, single-phase 50 Hz, and DC power sources are available to test systems. The open-area test site has a large, continuous metal ground plane (20 x 40 meters) and a 4-meter-diameter, flush-mounted turntable capable of supporting 15,000 pounds.

 

SwRI’s Bioengineering Section is ISO 13485:2003 certified and compliant with the FDA Quality System Regulation.

This flyer was published in February 2007. For more information about Testing and Evaluation of Medical Devices, contact Julie M. Pickard, Senior Research Engineer, Automation and Data Systems Division, Phone (210) 522-5437, Fax (210) 684-6147, Southwest Research Institute, P.O. Drawer 28510, San Antonio, Texas 78228-0510.

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