Clinical Engineering Course
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Questions and Answers

What regulatory organizations monitor and approve medical device manufacturers?

  • Clinical Engineering Department
  • Healthcare delivery organizations
  • Hospital planner &Medical Equipment Planning
  • Food & Drug Administration (FDA) and the CE Mark (correct)
  • Which department plays a role in technology evaluation, procurement, and equipment control in a hospital organization?

  • Outsourcing Clinical Engineering Service
  • Healthcare delivery department
  • Maintenance and Repair Department
  • Clinical Engineering Department (correct)
  • What is the purpose of Computerized Maintenance Management Systems (CMMS) in the context of medical device management?

  • To conduct clinical testing of medical devices
  • To evaluate the design of medical devices
  • To monitor and approve medical device manufacturers
  • To manage maintenance and repair of medical devices (correct)
  • What specific issues must be considered in medical device development?

    <p>Design, Manufacturing, Evaluation, Control</p> Signup and view all the answers

    Which organization is responsible for the approval of medical device design and manufacturing practices?

    <p>Food &amp; Drug Administration (FDA)</p> Signup and view all the answers

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