Chapters
  1. FDA Laws, regulations, and Medical Device Oversight
  2. FDA Inspections
  3. Quality System Requirements, Management Responsibility, and Personnel
  4. Design Controls
  5. Document Controls
  6. Purchasing Controls
  7. Identification and Traceability
  8. Production and Process Controls
  9. Acceptance Activities
  10. Nonconforming Product
  11. Corrective and Preventive Action
  12. Statistical Techniques
  13. Device Master Record
  14. Labeling and Packaging
  15. Handling, Storage, and Distribution
  16. Installation and Servicing
  17. Records - General Requirements, Device History Record
    (DHR), and Quality system Record (QSR)
  18. Complaint Files
  19. Medical Device Reporting
  20. Quality Audit

FDA Regulation Attachments

  1. FDA Quality System Regulation
  2. Medical Devices; Reports of Corrections and Removals
  3. Imports; Medical Devices, Reporting and Recordkeeping Requirements
  4. Establishment Registration and Device Listing for Manufacturers and Distributors of Device

Also Includes
Reference and List of FDA Offices
Acronym List
Glossary
Index

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