Table of Contents for Biomedical Quality Auditor Handbook


List of Figures and Tables ix
Preface xi
Notes to the Reader xii
Acknowledgments xiii
Part I U.S. Base Law and Regulations
Chapter 1 Base U.S. Law
2(31)
FDA Regulation of Medical Devices
2(1)
Summary of Medical Device Misbranding Regulations
3(2)
Summary of Adulteration Regulations
5(1)
FDA Inspection
6(14)
Recalls [FDCA § 518(e), 21 USC § 360h(e)]
20(2)
Voluntary Recalls
22(4)
Recall Strategy
26(1)
Elements of a Recall Strategy
26(7)
Chapter 2 U.S. Regulation
33(54)
Quality System Regulation
33(1)
Preamble
33(2)
Scope
35(3)
Definitions
38(4)
Management Responsibility
42(6)
Design Controls
48(6)
Documentation and Change Control
54(2)
Purchasing Controls
56(3)
Product Identification and Traceability
59(1)
Production and Process Controls
60(4)
Process Validation
64(2)
Acceptance Activities
66(1)
Nonconforming Product
67(1)
Corrective and Preventive Action
68(6)
Packaging and Labeling Controls
74(1)
Product Handling, Storage, Distribution, and Installation
75(3)
Records
78(4)
Complaint Handling
82(2)
Servicing
84(2)
Statistical Techniques
86(1)
Chapter 3 Labeling
87(6)
Labeling Regulation 21CFR 801
87(1)
Subpart A-General Labeling Provisions
87(6)
Chapter 4 Medical Device Reporting
93(36)
Medical Device Reporting Regulation 21 CFR 803
93(36)
Chapter 5 Recalls
129(3)
Voluntary Recalls
129(3)
Chapter 6 Establishment Registration and Listing
132(5)
Definitions
132(1)
Regulatory Requirement 21 CFR Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
133(3)
Summary
136(1)
Chapter 7 Device Tracking
137(11)
Device Tracking Regulation 21 CFR 821
137(1)
Subpart A General Provisions
138(8)
Subpart D Records and Inspections
146(2)
Chapter 8 Electronic Records and Signatures
148(5)
Electronic Records and Electronic Signatures 21 CFR Part 11
148(1)
Subpart B: Electronic Records
148(2)
SubPart C: Electronic Signatures
150(2)
Part 11: Compliance Policy Guide
152(1)
Summary
152(1)
Chapter 9 In Vitro Diagnostic Product Guidance
153(2)
FDA Standards
153(1)
In Vitro Diagnostic Products
154(1)
Chapter 10 Design Review Guidance
155(3)
Regulatory Requirement
155(1)
Discussion
156(2)
Chapter 11 Risk Management Guidance
158(5)
Risk Management Process
158(1)
Analysis of Risks
158(1)
Risk Estimation
159(1)
Risk Control
160(1)
Precedence of Actions for Risk Reduction
161(1)
Risk Management Report
161(1)
Risk Management Maintenance
162(1)
Summary
162(1)
Chapter 12 Quality System Inspection Technique
163(3)
Applicability
163(1)
Subsystems
164(1)
Sampling Tables
165(1)
Chapter 13 U.S. Compliance Programs for Medical Devices
166(4)
Discussion
166(4)
Part II Technical Knowledge
Chapter 14 Sterilization
170(14)
Definitions
174(3)
Methods
177(3)
Packaging of Sterile Products
180(4)
Chapter 15 Biocompatibility
184(2)
Chapter 16 Controlled Environments and Utility Systems
186(2)
Regulatory Requirement
186(1)
Utilities
187(1)
Facility Qualification
187(1)
Chapter 17 Software
188(7)
Software Development Process
189(1)
Requirements Definition
189(1)
Design Architecture
190(1)
Implementation
190(1)
Validation Test
190(1)
Design Transfer
191(1)
Design Release
191(1)
Engineering Changes
192(1)
How to Validate Process Software
192(1)
Guidelines for a Successful Software Development Program
193(2)
Chapter 18 Laboratory Testing
195(8)
Definitions
196(1)
Applicable Standards for Laboratory Testing
196(1)
Management Systems
197(1)
Operating and Testing Procedures
197(1)
Biological Testing
198(1)
Analytical Testing
198(5)
Chapter 19 Process Improvement Techniques
203(5)
Process Capability
203(1)
Six Sigma
203(1)
Lean Tools
204(1)
Measurement Systems Analysis
204(1)
Cost of Quality
205(1)
Qualitative versus Quantitative Analysis
205(1)
Attributes and Variable Data
206(1)
Quality Tool References
206(1)
Six Sigma References
207(1)
Lean References
207(1)
Measurement Systems Analysis References
207(1)
Cost of Quality References
207(1)
Chapter 20 Reprocessing
208(4)
Guidance Introduction
208(1)
Guidance Background
208(1)
Guidance Scope
209(3)
Part III International Standards and Guidance
Chapter 21 International Quality System Guidance
212(2)
Overview of European Harmonized Standards
212(1)
Discussion
213(1)
Harmonized Standards
213(1)
International Standards
213(1)
National Standards
213(1)
Chapter 22 The EU Medical Device Directives
214(13)
Definitions
215(2)
Purpose of the Medical Device Directives
217(1)
Requirements for Compliance
217(1)
Determining Whether the Product Has to Comply with the Medical Device Directives
218(1)
Discussion
218(1)
Classification of Medical Devices
219(1)
Discussion
219(1)
Conformity Assessment Route
220(1)
Compliance with Essential Requirements
220(1)
Risk Analysis
221(2)
Technical File/Design Dossier
223(1)
Authorized Representative
224(1)
Post-Market Surveillance-Including Device Incident Reporting (Vigilance)
224(1)
CE Marking
225(1)
Declaration of Conformity
226(1)
Chapter 23 International Auditing Guidelines
227(11)
GHTF Auditing Guidelines
227(2)
General Auditing Principles
229(4)
Audit Process
233(5)
Chapter 24 Common Medical Device Directives and Standards
238(2)
Chapter 25 International Regulations
240(5)
Canada
240(2)
Japan
242(1)
Australia
243(1)
Brazil
244(1)
Appendix A: Body of Knowledge 245(10)
Appendix B: Glossary 255(10)
Endnotes 265(4)
References 269(2)
Index 271