Mastering and Managing the FDA Maze

Medical Device Overview

Gordon Harnack

 304 Pages    1999
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There is a mountain of information on FDA regulation and compliance for medical device manufacturers. The task is daunting and very few busy manufacturers are regulatory mountain climbers. Reading the regulations provides only a small part of the picture. Understanding what the regulations mean and how compliance can be achieved in your environment is key.

In Mastering and Managing the FDA Maze, graphic icons organize the text and provide a visual aid to definitions, regulations, procedures, documents, records, and points to remember. Applicable chapters also end with an FDA Investigator Icon, which summarizes what the FDA investigator will expect to see during an investigation.


  • FDA Laws, Regulations and Medical Device Oversight
  • FDA Inspections
  • Quality System, Management Responsibilities and Personnel
  • Design Controls
  • Document Controls
  • Purchasing Controls
  • Identification and Traceability
  • Handling, Storage and Distribution
  • Installation and Servicing
  • Records, Device History Records and Quality System Records
  • Complaint Files
  • Medical Device Reporting
  • Quality Audits
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