Design Control Guidance and Quality Assurance Quiz for Medical Device Manufactur...
10 Questions
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Design Control Guidance and Quality Assurance Quiz for Medical Device Manufactur...

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@ReasonedAntigorite1133

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Questions and Answers

Which regulation incorporates design controls into the Quality System Regulation?

  • ISO 9001
  • FDA 21 CFR 820.30
  • Food and Drug Administration
  • Current Good Manufacturing Practice (CGMP) (correct)

    • What is the purpose of the design control framework established by the regulation?

  • To prescribe specific design practices for medical devices
  • To regulate the development and implementation of medical devices
  • To provide flexibility for manufacturers in developing design controls (correct)
  • To ensure consistency in quality assurance practices

    • What is the relationship between ISO 9001 and FDA 21 CFR 820.30?

  • ISO 9001 is a worldwide quality system requirement
  • ISO 9001 is a component of FDA 21 CFR 820.30 (correct)
  • ISO 9001 is a revision of FDA 21 CFR 820.30
  • ISO 9001 is a framework for developing design controls

    • What is the purpose of the Center for Devices and Radiological Health?

    <p>To ensure good quality assurance practices for medical devices</p> Signup and view all the answers

    What does the regulation prescribe for the practices that must be used for design controls?

    <p>A framework</p> Signup and view all the answers

    Which regulatory requirement includes design controls for medical device manufacturers?

    <p>Quality System Regulation</p> Signup and view all the answers

    What is the purpose of the design control framework established by the regulation?

    <p>To provide flexibility for manufacturers to develop design controls</p> Signup and view all the answers

    What does the regulation require manufacturers to do when developing and implementing design controls?

    <p>Follow specific practices prescribed by the regulation</p> Signup and view all the answers

    What is the relationship between FDA 21 CFR 820.30 and ISO 9001?

    <p>FDA 21 CFR 820.30 and ISO 9001 are unrelated</p> Signup and view all the answers

    What is the purpose of the Center for Devices and Radiological Health?

    <p>To revise the Current Good Manufacturing Practice requirements</p> Signup and view all the answers

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