The ASQ Certified Medical Device Auditor Handbook

Description

The ASQ Certified Medical Device Auditor Handbook (formerly The Biomedical Quality Auditor Handbook) was developed by the ASQ Medical Device Division (formerly Biomedical Division) in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the medical device community. It principally serves as a resource to candidates preparing for the Certified Medical Device Auditor (CMDA) certification exam. The fourth edition of this handbook has been reorganized to align with the 2020 certification exam Body of Knowledge (BoK) and reference list. The combination of this handbook with other reference materials can provide a well-rounded background in medical device auditing. Updates to this edition include: • A discussion of data privacy, data integrity principles, and the Medical Device Single Audit Program (MDSAP) • Current information about federal and international regulations • New content regarding human factors and usability engineering, general safety and performance requirements, labeling, validation, risk management, and cybersecurity considerations • A thorough explanation of quality tools and techniques Title page CIP data Table of Contents List of Figures and Tables 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 Quality System Requirements Design Controls Document Controls Purchasing Controls Identification and Traceability Production and Process Controls Acceptance Activities Nonconforming Product Corrective and Preventive Action Labeling and Packaging Control Handling, Storage, Distribution, and Installation Records Servicing Statistical Techniques Chapter 11_Post-market Surveillance U.S. Section 522 Post-Market Surveillance Studies U.S. Product Recalls FDA Policy European Union (EU) Device Incident Reporting (Vigilance) Part III_Technical Medical Device Knowledge Chapter 12_Risk Management ISO 14971 IEC 62366 ISO 13485 Chapter 13_Human Factors and Usability Engineering Human Factors References FDA Quality System Regulation (QSR) Usability Test Planning Post-Market Studies Chapter 14_Biological Evaluation ISO 10993 FDA Guidance—Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process Chapter 15_Packaging Introduction ISO 11607 ASTM D4169 ASTM F1980 Device Shelf Life Chapter 16_General Safety and Performance Requirements General Requirements Requirements Regarding Design and Manufacture Requirements Regarding the Information Supplied with the Device Additional Considerations for Safety and Performance Chapter 17_Software Development and Maintenance for Products Regulations Software Development Planning and Process Requirements Definition Cybersecurity System and Software Specification Software Design Implementation and Test Verification and Validation SOUP and COTS Software Design Transfer Design Changes Guidelines for a Successful Software Development Program Chapter 18_Labeling Labels Versus Labeling Use of Symbols Unique Device Identification (UDI) Global Trade Item Number (GTIN) Chapter 19_Controlled Environments and Utility Systems Controlled Environments Utility Systems Facility Qualification Chapter 20_Sterile Medical Devices Validation Studies Sterilization Methods Chapter 21_Laboratory Testing and Failure Analysis Approved Procedures Biological Testing Analytical Testing Failure Analysis Chapter 22_Validation Introduction Validation Determination Validation Documentation Rework Test Method Validation and Measurement System Analysis Chapter 23_Reprocessing/Reuse and Cleaning of Medical Devices FDA Guidance Process Overview General Considerations for Reusable Medical Devices General Considerations for Reprocessing Instructions in Device Labeling FDA’s Criteria for Reprocessing Instructions EU MDR Reprocessing for Single-Use Medical Devices Validation of Reprocessing Methods Validation of Cleaning Process Validation of Terminal Reprocessing Chapter 24_Common Medical Device Directives and Standards Directives Regulations Standards Chapter 25_Sources for New and Evolving Standards FDA-Recognized Consensus Standards Hierarchy of Standards in the EU EU Harmonized Standards Listing Medical Device Guidance (MEDDEV) Part IV_Quality Tools and Techniques Chapter 26_Quality Control and Problem-Solving Tools Pareto Charts Cause and Effect Flowcharts Statistical Process Control Check Sheets Scatter Diagram Histograms 5 Whys Is/Is Not (Kepner-Tregoe) Root Cause Analysis Plan-Do-Check-Act Setting Alert and Action Levels Chapter 27_Process Improvement Techniques Process Capability Six Sigma Lean Tools Measurement Systems Analysis Cost of Quality Chapter 28_Data Types and Sampling Qualitative and Quantitative Analysis Levels of Measurement Attributes and Variables Data Sampling Part V_Appendices Appendix A_Glossary of Terms Appendix B_Certified Medical Device Auditor (CMDA) Body of Knowledge (2020) Levels of Cognition Based on Bloom’s Taxonomy—Revised (2001) Appendix C_Certified Medical Device Auditor (CMDA) References (2020) End Notes Index About the Editor_Scott A. Laman