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Dec 04, 2024
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BIOE 8150 - Design, Manufacturing and Validation Methods for Reusable Medical Devices3 Credits (3 Contact Hours) Overview of design theories, methods and best practices governing the medical device reprocessing industry. Materials, fabrication processes and manufacturing techniques with an emphasis on remanufacturing, reprocessing and sustainability. Knowledge and skills needed to comply with process verification and validation requirements for Quality System Regulations with emphasis on a reprocessing approach. Preq: BIOE 8110 or consent of instructor.
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