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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
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)
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.
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
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)
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.