Manufacturing Assistance For Medical Devices 

Southwest Research Institute® (SwRI®) is an independent R&D firm that provides assistance in medical manufacturing in conjunction with our product development expertise. We can assist in the development of prototypes for evaluation or marketing purposes.

We help companies select the best manufacturer(s) for a given production application by performing the following tasks:

• Competitive bid procurement
• Supplier quality audits
• Design documentation transfer
• Process validation assistance or audit (IQ/OQ/PQ)
• Supplier evaluation for specific process requirements
• Feasibility studies
• Process control evaluation
• Risk assessment

Our Bioengineering Section is ISO 13485:2003 certified and compliant with the FDA Quality System Regulation. Clients can take advantage of SwRI’s broad range of manufacturing and process design experience to improve existing processes by focusing on the following areas:

• Automation
• Fixture and tooling design
• Operator ergonomics
• Safety
• Sensor development
• Automated visual inspection systems
• In-process monitoring, inspection and control
• Equipment modifications
• Line layouts
• Quality, product, inventory, and process tracking software
• Defect analyses
• Measurement and test equipment design and/or setup
• Statistical process optimization
• ID tags
• Aseptic processing
• Process simulation

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 Manufacturing Assistance For Medical Devices, contact Heather S. Hanson, Senior Research Engineer, Automation and Data Systems Division, Phone (210) 522-5798, Fax (210) 684-6147, Southwest Research Institute, P.O. Drawer 28510, San Antonio, Texas 78228-0510.

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