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Book Cover
E-book
Author Laman, Scott A

Title The ASQ Certified Medical Device Auditor Handbook
Edition 4th ed
Published La Vergne : ASQ Quality Press, 2021

Copies

Description 1 online resource (373 p.)
Contents Cover -- Title page -- CIP data -- Table of Contents -- Preface -- Acknowledgments -- Part I_Auditing -- Chapter 1_Auditing Fundamentals -- Audits by Purpose -- Audits by Method -- Audit Roles and Responsibilities -- Professional Conduct and Responsibilities -- Legal Consequences and Liability -- Data Privacy -- Chapter 2_Auditing and Inspection Processes -- Audit Preparation and Planning -- Audit Performance -- Audit Reporting -- Audit Follow-Up and Closure -- Data Integrity Principles -- ALCOA -- Chapter 3_Audit Procedural References -- ISO 19011:2018
Medical Device Single Audit Program (MDSAP) -- Quality System Inspection Technique (QSIT) -- FDA Compliance Program Guidance Manual (CPGM) 7382.845 -- Part II_Medical Device Quality Management System Requirements -- Chapter 4_FDA-Code of Federal Regulations (CFR) Title 21 -- Code of Federal Regulations (CFR) -- 21 CFR 4 Current Good Manufacturing Practice Requirements for Combination Products -- 21 CFR 7 Enforcement Policy -- 21 CFR 11 Electronic Records -- Electronic Signatures -- 21 CFR 58 Good Laboratory Practice for Nonclinical Laboratory Studies -- 21 CFR 801 Labeling
21 CFR 803 Medical Device Reporting -- 21 CFR 806 Corrections and Removals -- 21 CFR 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices -- 21 CFR 807 Subpart E-Premarket Notification Procedures -- 21 CFR 820 Quality System Regulation -- 21 CFR 821 Medical Device Tracking Requirements -- 21 CFR 830 Unique Device Identification -- Chapter 5_U.S. Requirements (FD&C Act, 201, 301-304, 501-502, 510, 513, 518, 522, 704) -- Introduction -- FD&C Act Chapter II: Definitions -- FD&C Act Chapter III: Prohibited Acts and Penalties
FD&C Act Chapter V: Drugs and Devices -- FD&C Act Chapter VII: General Authority -- Chapter 6_The EU Medical Device Regulation -- Introduction -- The MDD to MDR Transition -- Scope and Purpose of the Medical Device Regulation -- Requirements for Compliance -- Determining Whether the Product Must Comply with the Regulation -- Types of Medical Devices -- Classification of Medical Devices -- Quality Management Systems, Processes, and Resources for Medical Devices -- Safety and Performance Requirements -- Risk Management -- Clinical Evaluation -- Technical Documentation -- Distribution
Device and Manufacturer Registration -- Conformity Assessment -- CE Marking -- Market Launch -- Post-Market Launch and Maintenance -- Summary -- Chapter 7_Other International Regulations -- Introduction -- Canada -- Japan -- Australia -- Brazil -- China -- Chapter 8_Requirements for In Vitro Diagnostic (IVD) Devices -- Introduction -- 21 CFR 809 -- FDA-Recognized Standards -- IVDR 2017/746 -- Chapter 9_International Standards for Quality Systems -- ISO 9001 -- ISO 13485 -- ISO/IEC 17025 -- Chapter 10_Quality System Regulation (QSR) Requirements -- Introduction -- Preamble -- General Provisions
Notes Description based upon print version of record
Quality System Requirements
Subject Auditing -- Handbooks, manuals, etc
Auditing -- Mathematical models
Auditing
Auditing -- Mathematical models
Genre/Form Handbooks and manuals
Form Electronic book
ISBN 9781951058371
1951058372