Handbook of Medical Device Design 1st Edition by Richard Fries 0367249405 9780367249403

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ISBN 10: 0367249405

ISBN 13: 9780367249403

Author: Richard C. Fries

First published in 2001: This handbook has been written to give those professionals working in the development and use of medical devices practical knowledge about biomedical technology, regulations, and their relationship to quality health care.

Handbook of Medical Device Design 1st Table of contents:

Section 1 Standards and Regulations

Chapter 1 FDA Regulations

1.1 History of Device Regulation

1.2 Device Classification

1.3 Registration and Listing

1.4 Good Laboratory Practices (GLP)

1.5 Good Manufacturing Practices (GMP)

1.6 Human Factors

1.7 Design Control

1.8 Software

1.9 The FDA Inspection

1.10 Dealing with the FDA

References

Chapter 2 Preparing an FDA Submission

2.1 Device Classification

2.2 The Traditional 510(k)

2.3 Special 510(k)

2.4 Abbreviated 510(k)

2.5 Declaration of Conformity to a Recognized Standard

2.6 PMA Application

2.7 Investigational Device Exemptions

2.8 Software Classification

References

Chapter 3 European Standards and Regulations

3.1 The European Regulatory Scene

3.2 European Directives

3.3 European Standardization Bodies

3.4 European Standards Development Process

3.5 Other European Standards Considerations

3.6 Conformity Assessment and Testing

3.7 European Organization for Testing and Certification

3.8 Examples of European Directives and Regulations

3.9 Medical Informatics

3.10 The Global Harmonization Task Force

References

Chapter 4 The Medical Device Directives

4.1 Definition of a Medical Device

4.2 The Medical Device Directives Process

4.3 Choosing the Appropriate Directive

4.4 Identifying the Applicable Essential Requirements

4.5 Identification of Corresponding Harmonized Standards

4.6 Assurance that the Device Meets the Essential Requirements and Harmonized Standards

4.7 Classification of the Device

4.8 Decision on the Appropriate Conformity Assessment Procedure

4.9 Type Testing

4.10 Identification and Choice of a Notified Body

4.11 Establishing a Declaration of Conformity

4.12 Application of the CE Mark

4.13 Conclusion

References

Chapter 5 The Basics of ISO 9001

5.1 Historical Perspective

5.2 ISO 9001 Revision Year 2000

5.3 Requirement Synopses

References

Chapter 6 Design of Medical Devices for the Canadian Market

6.1 Fundamental Safety and Effectiveness Principles

6.2 Device Classification

6.3 Labeling

6.4 Standards and the Design Process

6.5 Implant Registration

6.6 In Vitro Diagnostic Devices (IVDDs)

6.7 Electrically Operated Medical Devices

6.8 Medical Devices Incorporating Plumbing Features

6.9 Summary

References

Chapter 7 Pacific Rim Standards and Regulations

7.1 Australia

7.2 Japan

7.3 Russia

7.4 China

References

Chapter 8 Overview of Software Standards

8.1 History

8.2 Major Standards Organizations

8.3 The FDA’s Interest in Standards

8.4 ISO/IEC 12207 Information Technology – Software Life Cycle Process

8.5 The FDA Recognizes ISO/IEC 12207

8.6 Tailoring ISO/IEC 12207 for the Medical Device Business Sector

8.7 Summary

References

Section 2 Determining and Documenting Requirements

Chapter 9 Defining the Device

9.1 The Product Definition Process

9.2 Overview of Quality Function Deployment

9.3 The QFD Process

9.4 Summary of QFD

9.5 The Business Proposal

References

Chapter 10 Documenting Product Requirements

10.1 Requirements, Design, Verification, and Validation

10.2 The Product Specification

10.3 Specification Review

10.4 The Design Specification

10.5 The Software Quality Assurance Plan (SQAP)

10.6 Software Requirements Specification (SRS)

10.7 The Software Design Description (SDS)

References

Chapter 11 Medical Device Records

11.1 The Design History File (DHF)

11.2 The Device Master Record (DMR)

11.3 The Device History Record (DHR)

11.4 The Technical Documentation File (TDF)

11.5 A Comparison of the Medical Device Records

References

Section 3 The Design Phase

Chapter 12 Hazard and Risk Analysis

12.1 Hazards, Risks, and Mitigation

12.2 Hazard Analysis

12.3 Risk Analysis

12.4 Risk Analysis Matrix

12.5 Software Hazard Analysis

12.6 Safety Requirements Specification

12.7 Hazard Analysis and Quality Control

12.8 Conclusion

References

Chapter 13 Hardware Design

13.1 Block Diagram

13.2 Redundancy

13.3 Component Selection

13.4 Component Derating

13.5 Safety Margin

13.6 Load Protection

13.7 Environmental Protection

13.8 Product Misuse

13.9 Design for Variation

13.10 Design of Experiments

13.11 Design Changes

13.12 Design Reviews

References

Chapter 14 Software Design

14.1 Fundamentals of Software Engineering Management

14.2 Planning Software Development

14.3 Choosing the Software Development Process Model

14.4 Development Process Models for High Level of Concern

14.5 Development Process Models for Low Level of Concern

14.6 Choosing a Design Method

14.7 Choosing a Programming Language

14.8 Estimating and Scheduling

14.9 Tracking Progress

14.10 Necessary Technical Software Development Activities

14.11 Software Requirements Analysis

14.12 Software Hazard Analysis

14.13 Requirements Traceability

14.14 Software Architectural Design

14.15 Detailed Design

14.16 Implementation (Coding)

14.17 Integration

14.18 Software Configuration Management

14.19 Conclusion

References

Chapter 15 Human Factors Engineering

15.1 What Is Human Factors?

15.2 Human Factors Process

15.3 Specifying the User Interface

15.4 Additional Human Factors Design Considerations

15.5 Documentation

15.6 Anthropometry

15.7 Alarms and Signals

15.8 Labeling

15.9 Software

References

Chapter 16 Biocompatibility

16.1 The FDA and Biocompatibility

16.2 International Regulatory Efforts

16.3 Device Category and Choice of Test Programs

16.4 Preparation of Extracts

16.5 Biological Control Tests

16.6 Tests for Biological Evaluation

16.7 Alternative Test Methods

References

Chapter 17 Reliability Assurance

17.1 Reliability versus Unreliability

17.2 Quality versus Reliability

17.3 The Definition of Reliability

17.4 History of Reliability

17.5 Types of Reliability

17.6 Device Reliability

17.7 Optimizing Reliability

17.8 Reliability’s Effect on Medical Devices

17.9 Initial Reliability Prediction

17.10 Design for Variation

References

Chapter 18 Product User Guides

18.1 Why User Documentation Is Important

18.2 It’s a Team Effort

18.3 How a Manual Evolves

18.4 Style Guides

18.5 Manual Tips

References

Chapter 19 Translation: “It’s A Small World After All”

19.1 Defining Translation and Localization

19.2 The Importance of Good English

19.3 The Translation Process

19.4 Symbols and Graphics

19.5 The Importance of Glossaries

19.6 Choosing a Translator

19.7 It’s a Small World

References

Chapter 20 Liability

20.1 Negligence

20.2 Strict Liability

20.3 Breach of Warranty

20.4 Defects

20.5 Failure to Warn of Dangers

20.6 Plaintiffs Conduct

20.7 Defendant’s Conduct

20.8 Defendant-Related Issues

20.9 Manufacturer’s and Physician’s Responsibilities

20.10 Conclusion

References

Chapter 21 Intellectual Property

21.1 Patents

21.2 Copyrights

21.3 Trademarks

21.4 Trade Secrets

References

Section 4 Verification and Validation

Chapter 22 Testing

22.1 Purposes

22.2 Proper Setup

22.3 Running the Test

22.4 Analyzing the Outcome

22.5 Limits to Analysis

22.6 Conclusion

References

Chapter 23 Overview of Verification and Validation for Embedded Software in Medical Systems

23.1 Verification and Validation Planning

23.2 Test Development

23.3 Test Execution and Reporting

References

Chapter 24 Software Verification and Validation

24.1 Planning Software Verification and Validation

24.2 Static Verification Techniques

24.3 Modeling Techniques

24.4 Dynamic Testing Techniques

24.5 Verification Activities

24.6 Verifying Safety

24.7 Verification Measurement

24.8 Software Validation

24.9 Conclusion

References

Chapter 25 Reliability Evaluation

25.1 Standard Tests

25.2 Environmental Testing

25.3 Accelerated Testing

25.4 Sudden Death Testing

25.5 The Sudden Death Test

References

Chapter 26 Analysis of Test Results

26.1 Failure Rate

26.2 Mean Time Between Failures (MTBF)

26.3 Reliability

26.4 Confidence Level

26.5 Confidence Limits

26.6 Minimum Life

26.7 Graphical Analysis

References

Section 5 The Manufacturing/Field Phase

Chapter 27 Quality System Regulations and Manufacturing

27.1 History of the Quality System Regulations

27.2 Scope

27.3 General Provisions

27.4 Design for Manufacturability

27.5 Design for Assembly

27.6 The Manufacturing Process

References

Chapter 28 Configuration Management

28.1 Configuration Identification

28.2 Configuration Audits

28.3 Configuration Management Metrics

28.4 FDA’s View of Configuration Management

28.5 Status Accounting

References

Chapter 29 The Quality System Audit

29.1 Preparation

29.2 What to Expect on Audit Day

29.3 Surveillance

References

Chapter 30 Analysis of Field Data

30.1 Analysis of Field Service Reports

30.2 Failure Analysis of Field Units

30.3 Warranty Analysis

References

Section 6 Appendices

Appendix 1 Chi Square Table

Appendix 2 Percent Rank Tables

Appendix 3 Glossary

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