Title Mastering and Managing the FDA Maze Medical Device Overview

Edition 2nd ed Published La Vergne : ASQ Quality Press, 2014

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Description 1 online resource (501 p.) Contents 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 Notes Description based upon print version of record FDA Accredited UDI Organizations Subject United States. Food and Drug Administration Safety and Innovation Act. SUBJECT Food and Drug Administration Safety and Innovation Act (United States) fast Subject Medical instruments and apparatus -- Safety regulations -- United States Medical instruments and apparatus -- Safety regulations United States Form Electronic book ISBN 9781636940465 1636940463

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