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 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, including 510K and PMA.
quality management • 21CFR820 • biomedical engineering • biomedical technology • medical device • biotechnology • fluid dynamics • MEMS • spinal fusion • ACL repair • tissue engineering • knee replacement • facet replacement • biosensors • fusion monitoring • heat stress monitor • life detection