Mastering and Managing the FDA Maze : Medical Device Overview.

Cover -- Title page -- CIP data -- Contents -- Figures and Tables -- Acknowledgments -- What is New? -- Introduction -- Chapter 1_FDA Laws, Regulations, and Medical Device Oversight -- Scope -- FDA Laws -- FDA Regulations -- FDA Medical Device Oversight -- Chapter 2_FDA Inspections -- Scope -- FDA Inspections -- Chapter 3_Quality System Requirements, Management Responsibilities, and Personnel -- Scope -- Quality System -- Subpart B-Quality System Requirements -- FDA Inspection of Quality System Requirements -- Chapter 4_Design Controls -- Scope -- Design Controls -- FDA Inspections of Design Controls -- Chapter 5_Document Controls -- Scope -- Document Controls -- FDA Inspection of Document Controls -- Chapter 6_Purchasing Controls -- Scope -- Purchasing Controls -- FDA Inspection of Purchasing Controls -- Chapter 7_Identification and Traceability -- Scope -- Identification and Traceability -- FDA Inspection of Identification and Traceability -- Chapter 8_Production and Process Controls -- Scope -- Production and Process Controls -- FDA Inspection of Production and Process Controls -- Chapter 9_Acceptance Activities -- Scope -- Acceptance Activities -- FDA Inspection of Acceptance Activities -- Chapter 10_Nonconforming Product -- Scope -- Nonconforming Product -- FDA Inspection of Nonconforming Product -- Chapter 11_Corrective and Preventive Action -- Scope -- Corrective and Preventive Action -- FDA Inspection of Corrective and Preventive Action -- Chapter 12_Statistical Techniques -- Scope -- Statistical Techniques -- FDA Inspection of Statistical Techniques -- Chapter 13_Device Master Record (DMR) -- Scope -- Device Master Record (DMR) -- FDA Inspection of the Device Master Record -- Chapter 14_Labeling and Packaging -- Scope -- Labeling -- Device Labeling -- Subpart K-Labeling and Packaging Control -- FDA Inspection of Labeling -- Packaging.

FDA Inspection of Packaging -- Chapter 15_Handling, Storage, and Distribution -- Scope -- Handling -- FDA Inspection of Handling -- Storage -- FDA Inspection of Storage -- Distribution -- Subpart L-Distribution -- FDA Inspection of Distribution -- Chapter 16_Installation and Servicing -- Scope -- Installation -- FDA Inspection of Installation -- Servicing -- FDA Inspection of Servicing -- Chapter 17_Records-General Requirements, Device History Record (DHR), and Quality System Record (QSR) -- Scope -- Records -- Subpart M-General Requirements -- FDA Inspection of Records-General Requirements -- Subpart M-Device History Record (DHR) -- FDA Inspection of Device History Record -- Quality System Record -- FDA Inspection of the Quality System Record -- Chapter 18_Complaint Files -- Scope -- Complaint Files -- FDA Inspection of Complaint Files -- Chapter 19_Unique Device Identification (UDI) System Including Applicable Parts of 21 CFR 830 and 21 CFR 801 -- Scope -- Unique Device Identification -- FDA Inspection of Unique Device Identification -- FDA Inspection of Labeling -- FDA Accredited UDI Organizations -- Chapter 20_Medical Device Reporting -- Scope -- Medical Device Reporting -- Chapter 21_Medical Devices-Reports of Corrections and Removals -- Scope -- Reports of Corrections and Removals -- FDA Inspection of Corrections and Removals -- Chapter 22_Quality Audit -- Scope -- Quality Audit -- FDA Inspection of Auditing -- Appendices -- Appendix A -- Appendix B -- Appendix C -- Appendix D -- Appendix E -- Appendix F -- References and List of FDA Offices -- Acronym List -- Glossary -- Index.

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Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2024. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.