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Configuration Management and Performance Verification of Explosives-Detection Systems (1998) / Chapter Skim
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Appendix D: Alternative Quality Standards
Pages 61-62

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From page 61...
... mandate is to ensure the safety and effectiveness of medical devices 61 through premarket submissions and postmarket regulations. Postmarket regulations employed by the FDA include surveillance reports from manufacturers and device users, as well as requirements regarding manufacturing practices.
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From page 62...
... would likely conduct an overview audit for ensuring regulatory compliance, whereas a third-party auditor would ensure that ISO standards were being maintained. This regulatory scenario may lend itself well to FAA regulation of explosives-detection equipment.
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Key Terms

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  • gmp regulation
  • manufacturing practices

  • quality management
  • postmarket regulations
  • management program
  • manufacturer document
  • regulations employed

  • attractive feature
  • specific device
  • corrective action
  • regarding existing
  • including design

  • preproduction design
  • design results
  • regulation requires
  • device complaints
  • medical device

  • device design
  • product design
  • include surveillance
  • manufacturing cycle
  • device manufactured

  • surveillance reports
  • audits conducted
  • manufacture processes
  • device manufacturers
  • faa requires


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