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Book by Association for the Advancement of Medical Instrumentation,

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This new version combines the first edition of The Quality System Compendium and the Supplement to The Quality System Compendium into a single volume, and provides updated and new information on critical regulatory areas that have seen significant changes in the years since both textbooks were published.

Updates include:

  • New chapters on combination products and risk management for medical devices.
  • An updated chapter on FDA's organization and regulatory strategies, including the recent reauthorization of MDUFMA.
  • Revised chapters on quality systems, design controls, and process validation, to reflect current FDA and industry thinking.
  • A bibliography that includes current references and websites.
  • A full copy of the Final Rule for the Quality System regulation, including a list of all Technical Amendments published since 1996.
  • A comprehensive index.
  • User-friendly tabs for easy navigation.

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