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Biomedical Engineering Design and the Promotion of High Value Relationships with Clinical Medicine

Biomedical Engineering Design and the Promotion of High Value Relationships with Clinical Medicine. Robert Hitchcock. Background. A highly regulated industry. Collaborative development environment. Utah BioDesign. University resources and vision. Course Highlights.

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Biomedical Engineering Design and the Promotion of High Value Relationships with Clinical Medicine

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  1. Biomedical Engineering Design and the Promotion of High Value Relationships with Clinical Medicine Robert Hitchcock

  2. Background A highly regulated industry Collaborative development environment Utah BioDesign University resources and vision

  3. Course Highlights Projects are initiated by clinicians Students interact with clinicians Focus on FDA Quality System Regulation – Design Controls Projects required to follow Standard Operating Procedures

  4. Regulatory Environment USPTO FDA CSA ASTM IEC EC JCAHO GHTF ISTA ISO

  5. Systematic Allows organizations to develop design processes that meet their needs. Team based Multidisciplinary teams are empowered to make decisions. Customer focused Requirements play a key role in driving specifications and validation. Robust Verification and validation ensure a higher quality design. Required by law Why Design Control?

  6. Design Control SOPs Approach used by all medical device and pharmaceutical companies Interprets FDA QSR for design course Creates common ground for students Provides consistent guidelines for assessment “Audit" students as part of their assessment

  7. Design Control SOPs

  8. Course Timeline – Spring / Fall

  9. Bone marrow aspiration device Heart patch for stem cell delivery Third heart sound monitor Optically guided feeding tube Fiber optic respirometer Projects

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