The ASQ Certified Medical Device Auditor Handbook

The ASQ Certified Medical Device Auditor Handbook

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Bibliographic Details
Main Author: Laman, Scott A.
Format: eBook
Language:English
Published: La Vergne : ASQ Quality Press, 2021.
Edition:4th ed.
Subjects:
Auditing > Handbooks, manuals, etc.
Auditing > Mathematical models.
Auditing
Auditing > Mathematical models
Handbooks and manuals
Online Access:Click for online access
Table of 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

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