دانلود کتاب Medical-Grade Software Development: How to Build Medical-Device Products That Meet the Requirements of IEC 62304 and ISO 13485

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Cover
Half Title
Title Page
Copyright Page
Dedication
Contents
List of Figures and Tables
Preface
Acknowledgments
About the Authors
Chapter 1 What to Know Before Getting Started
1.1 There Is No One Correct Answer to Anything
1.2 Why Do We Need a Standard at All?
1.3 What Is Medical-Grade Software?
1.4 Software Is Classified by the Safety Concerns Associated with It
1.5 Software Is Made of Units, Items, and Systems
1.6 Software Development Has a Life Cycle
1.7 Everything Is a Process, and Those Consist of Activities and Tasks
1.8 IEC 62304 Does Not Insist on a Specific Process Structure
1.9 IEC 62304 Does Not Impose a Documentation Set
1.10 Applicable Regulations as Part of the Requirements
1.11 Building on the Quagmire That Surrounds IEC 62304
1.12 Retaining Trust at Each Step of the Way Is Perhaps the Most Critical of Tasks
1.13 The Relationship between Code and Documentation is at the Core of the Marriage, Even after a Shotgun-Wedding
1.14 Evaluation, Review, Verification, and Validation
1.15 How Many Reviews Is Enough?
1.16 How Much Testing Is Enough?
1.17 Fail and Pass
1.18 One Step Forward, Two Steps Back
1.19 Continuous Improvement
1.20 What Is SOUP?
1.21 Configuration Items and Controlled Changes
1.22 Legacy Software Has a Dedicated Pathway Through IEC 62304
1.23 Software Always Fails, and Other Software Risk Beliefs
1.24 Certification Bodies and the Notified Body
1.25 Safety Is Relative
Chapter 2 ISO 13485 as the Backbone of It All
2.1 The Whole of the Quality Management System
2.2 The Process for Product Realization
Chapter 3 IEC 62304 as The Flesh around The Bones
3.1 The Past, Present, and Future
3.1.1 Times of the Primordial Ooze
3.1.2 Modern Times
3.1.3 The Future
3.2 Contents
3.2.1 Foreword
3.2.2 Introduction
3.2.3 Clause 1: Scope
3.2.4 Clause 2: Normative References
3.2.5 Clause 3: Terms and Definitions
3.2.6 Clause 4: General Requirements
3.2.7 Clause 5: Software Development Process
3.2.8 Clause 6: Software Maintenance Process
3.2.9 Clause 7: Software Risk-Management Process
3.2.10 Clause 8: Software Configuration Management Process
3.2.11 Clause 9: Software Problem Resolution Process
3.2.12 Annex A – Rationale for the Requirements of This Standard
3.2.13 Annex B – Guidance on the Provisions of This Standard
3.2.14 Annex C – Relationship to Other Standards
3.2.15 Annex D – Implementation
Chapter 4 General Requirements
4.1 Quality Management Systems
4.2 Risk Management
4.3 Software Safety Classification
4.3.1 Classification Formula
4.3.2 What Is Harm?
4.3.3 Accept That All Software Will Fail
4.3.4 Use of External Risk Controls
4.3.5 Reducing Both Probability and Severity
4.3.6 Recording and Inheriting the Classification
4.3.7 Final Remarks
4.4 Legacy Software
4.4.1 Risk-Management Activities
4.4.2 Gap Analysis
4.4.3 Gap Closure Activities
4.4.4 Rationale for Use of Legacy Software

Chapter 5 Software Development
5.1 Development Planning
5.1.1 Expectations from ISO 13485
5.1.1.1 Process Documentation
5.1.1.2 Planning Documentation
5.1.2 Expectations from IEC 62304
5.1.2.1 Process Documentation
5.1.2.2 Planning Documentation
5.1.3 Suggested Synthesis
5.1.3.1 Standard Operating Procedure (SOP)
5.1.3.2 System Development Plan
5.1.3.3 Software Development Plan (SDP)
5.1.3.4 Other Plans Mentioned
5.1.3.5 Use of Systems Instead of Documents
5.2 Requirements Analysis
5.2.1 Expectations from ISO 13485
5.2.1.1 Inputs for Requirements
5.2.1.2 Finalizing Requirements
5.2.2 Expectations from IEC 62304
5.2.2.1 Inputs for Requirements
5.2.2.2 Finalizing Requirements
5.2.3 Suggested Synthesis
5.2.3.1 Requirements Elicitation
5.2.3.2 Requirements Review (i.e., Design Input Review)
5.3 Architectural Design B C
5.3.1 Expectations from ISO 13485
5.3.3.1 Developing the Architecture Design
5.3.3.2 Verifying the Architectural Design
5.3.2 Expectations from IEC 62304
5.3.2.1 Developing the Architecture Design
5.3.2.2 Verifying the Architectural Design
5.3.3 Suggested Synthesis
5.4 Detailed Design B C
5.4.1 Expectations from ISO 13485
5.4.1.1 Developing the Detailed Design
5.4.1.2 Verifying the Detailed Design
5.4.2 Expectations from IEC 62304
5.4.2.1 Developing the Detailed Design B C
5.4.2.2 Verifying the Detailed Design C
5.4.3 Suggested Synthesis
5.5 Unit Implementation and Verification
5.5.1 Expectations from ISO 13485
5.5.1.1 Unit Implementation
5.5.1.2 Unit Verification
5.5.2 Expectations from IEC 62304
5.5.2.1 Unit Implementation
5.5.2.2 Unit Verification B C
5.5.3 Suggested Synthesis
5.6 Integration and Integration Testing B C
5.6.1 Expectations from ISO 13485
5.6.2 Expectations from IEC 62304
5.6.2.1 Integration Plan B C
5.6.2.2 Integrating Software Units B C
5.6.2.3 Integration Verification B C
5.6.2.4 Integration Testing B C
5.6.3 Suggested Synthesis
5.7 Software-System Testing
5.7.1 Expectations from ISO 13485
5.7.2 Expectations from IEC 62304
5.7.2.1 Establishing and Performing Testing
5.7.2.2 Verification of System Testing
5.7.3 Suggested Synthesis
5.8 Release
5.8.1 Expectations from ISO 13485
5.8.1.1 D&D Output Review
5.8.1.2 Verification
5.8.1.3 Validation
5.8.1.4 Production and Service Provision
5.8.1.5. Release
5.8.2 Expectations from IEC 62304
5.8.2.1 D&D Output Review
5.8.2.2 Verification
5.8.2.3 Validation
5.8.2.4 Production and Service Provision
5.8.2.5 Release
5.8.3 Suggested Synthesis
5.8.3.1 Design Output Review (DOR)
5.8.3.2 Validation Report
5.8.3.3 Design Transfer Review (DTR)
5.9 The Parts Left Out by IEC 62304
5.9.1 Conducting Reviews in D&D Stages
5.9.2 D&D Verification
5.9.3 D&D Validation
Chapter 6 Software Maintenance
6.1 Software Maintenance Plan
6.1.1 Expectations from ISO 13485
6.1.2 Expectations from IEC 62304
6.1.3 Suggested Synthesis
6.2 Problem and Modification Analysis
6.2.1 Expectations from ISO 13485
6.2.2 Expectations from IEC 62304
6.2.3 Suggested Synthesis
6.3 Modification Implementation
6.3.1 Expectations from ISO 13485
6.3.2 Expectations from IEC 62304
6.3.3 Suggested Synthesis
6.4 The Parts Left Out By IEC 62304
Chapter 7 Risk Management
7.1 Analysis of Software Contributing to Hazardous Situations B C
7.1.1 Expectations from ISO 13485
7.1.2 Expectations from IEC 62304
7.1.3 Suggested Synthesis
7.2 Risk-Control Measures B C
7.2.1 Expectations from ISO 13485
7.2.2 Expectations from IEC 62304
7.2.3 Suggested Synthesis
7.3 Verification of Risk-Control Measures B C
7.3.1 Expectations from ISO 13485
7.3.2 Expectations from IEC 62304
7.3.3 Suggested Synthesis
7.4 Risk Management of Software Changes
7.4.1 Expectations from ISO 13485
7.4.2 Expectations from IEC 62304
7.4.3 Suggested Synthesis
7.5 The Parts Left Out by IEC 62304
Chapter 8 Configuration Management
8.1 Identification of Configuration Items
8.1.1 Expectations from ISO 13485
8.1.2 Expectations from IEC 62304
8.1.3 Suggested Synthesis
8.1.3.1 Version Numbering
8.1.3.2 What Items Should Be Tracked?
8.1.3.3 Configuration Management over Databases
8.2 Change Control (Incl. Verification)
8.2.1 Expectations from ISO 13485
8.2.2 Expectations from IEC 62304
8.2.2.1 Approval of Change Requests
8.2.2.2 Implementation of Changes
8.2.2.3 Verification of Changes
8.2.2.4 Traceability over Changes
8.2.3 Suggested Synthesis
8.3 History of Controlled Items
8.3.1 Expectations from ISO 13485
8.3.2 Expectations from IEC 62304
8.3.3 Suggested Synthesis
8.4 The Parts Left Out by IEC 62304
Chapter 9 Problem Resolution
9.1 Prepare Problem Reports
9.1.1 Expectations from ISO 13485
9.1.2 Expectations from IEC 62304
9.1.3 Suggested Synthesis
9.2 Investigate the Problem
9.2.1 Expectations from ISO 13485
9.2.2 Expectations from IEC 62304
9.2.3 Suggested Synthesis
9.3 Advise Relevant Parties
9.3.1 Expectations from ISO 13485
9.3.2 Expectations from IEC 62304
9.3.3 Suggested Synthesis
9.4 Use Change-Control Processes
9.4.1 Expectations from ISO 13485
9.4.2 Expectations from IEC 62304
9.4.3 Suggested Synthesis
9.5 Maintain Records
9.5.1 Expectations from ISO 13485
9.5.2 Expectations from IEC 62304
9.5.3 Suggested Synthesis
9.6 Analyze Problems for Trends
9.6.1 Expectations from ISO 13485
9.6.2 Expectations from IEC 62304
9.6.3 Suggested Synthesis
9.7 Verify Software Problem Resolution
9.7.1 Expectations from ISO 13485
9.7.2 Expectations from IEC 62304
9.7.3 Suggested Synthesis
9.8 Test Documentation Contents
9.8.1 Expectations from ISO 13485
9.8.2 Expectations from IEC 62304
9.8.3 Suggested Synthesis
9.9 The Parts Left Out by IEC 62304
Chapter 10 Integration with Your Qms
10.1 Write Your Product Realization Processes in the QMS
10.2 Develop Your Planning Documentation According to Your QMS
10.3 Execute on Your Plans as Expected by Your Arrangements
10.4 Execute on Your Post Release Activities
10.5 Keep Your QMS in Good Shape
Chapter 11 Technical Documentation
11.1 What Is Technical Documentation Anyway?
11.2 Process Documents
11.3 Development Records
11.4 The Audit Package
Chapter 12 Seeing Into The Future
12.1 Agile Software Development
12.1.1 What Is Agile Anyway?
12.1.2 Development Life Cycle in a Regulated Environment
12.2 IEC 82304-1 on Health Software
12.2.1 Product Requirements
12.2.2 Software Development Process
12.2.3 Validation
12.2.4 Product Documentation
12.2.5 Post-Market Activities
12.3 Segregation in Software Architecture
12.4 Risk Management Influenced by FMEA
12.5 Usability Engineering
12.6 Cybersecurity
12.6.1 Cybersecurity Over Product Life Cycle
12.6.2 Cybersecurity Across Jurisdictions
12.6.3 IEC 81001-5-1
12.6.4 ISO/IEC 27001
12.7 Artificial Intelligence
12.8 Cloud Computing
12.9 Edge Intelligence
Chapter 13 Conformity Assessment
13.1 Requirements Placed on the Assessor
13.2 The Assessment
13.3 Typical Shortcomings in Assessments
13.4 What Happens Afterward?
Chapter 14 Regulatory Approval
14.1 Benefits of the IEC 62304 Test Report
14.2 ISO 13485 Certification
14.3 Medical-Device Conformity Assessment
14.4 Changes
Chapter 15 Business as Usual
15.1 The Everyday Processes to Now Run
15.2 The Future of IEC 62304
15.3 The Future of ISO 13485
15.4 The Joy of Compliance
16 Conclusions
References
Index