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The U.S. Food and Drug Administration (FDA) requires that design, development, testing, and manufacturing of medical devices be performed in accordance with 21CFR820, Quality System Regulation, Medical Devices; Current Good Manufacturing Practice.
The Southwest Research Institute (SwRI) ISO 13485:2003 Quality Management System is compliant to FDA regulations as well as European medical device directives and Health Canada CMDCAS.
The Biomedical Engineering Section provides assistance with the design, development, and testing of medical devices. Documentation is provided to satisfy the requirements for U.S. and international registration of medical devices. SwRI has assisted in successful FDA medical device approval submissions such as 510K and PMA.
For more information about the biomedical engineering quality management system at SwRI or how you can contract with SwRI, please contact Keith Bartels, Ph.D., at kbartels@swri.org or (210) 522-6062.
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Southwest Research Institute® (SwRI®), headquartered in San Antonio, Texas, is a multidisciplinary, independent, nonprofit, applied engineering and physical sciences research and development organization with 12 technical divisions. |
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March 27, 2009 |
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