Software Development and Quality Assurance for the Healthcare Manufacturing Industries Third edition by Steven Mallory ISBN 978-1574911367 1574911368
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Product details:
ISBN 10: 1574911368
ISBN 13: 978-1574911367
Author: Steven R. Mallory
Completely revised and updated, this book is a practical guide for anyone involved in all levels of the development and quality assurance of software programs for healthcare products – particularly in the medical device and equipment manufacturing industries. From high-level strategies and mechanics to detailed flow charts, tables, and sample forms, the text helps assure that all requisite phases of development and testing have been considered and implemented as readers develop a complete, integrated, cohesive, and interrelated software quality assurance program. Readers will learn how to design, implement, and manage the software development effort, as well as how to audit the program.
Table of contents:
1. How Did a Nice Discipline like Quality Get Mixed Up with Software Engineering?
Historical Perspectives of Software Quality Assurance
The Need for Software Quality Assurance
Complexity and Precision in Programming
Hardware versus Software: Similar but Different
Built-in Software Quality
Is It Soup Yet?
Software Quality Dimensions
2. The Components of a Software Quality Assurance Program
Aspects of Quality
Overview of the System Design and Software Design Process
Software Standards and Procedures
Implementation of a Software Quality Assurance Program
Software Quality Assurance Education
3. The Software Quality Assurance Program: Foundations of Methodology and Process
Software Methodology and Process Definition
Software Methodology and Process Documentation
Software Policy Guidelines
Software Quality Assurance in the Maintenance Cycle
4. The Software Quality Assurance Program: Project Software Estimations
Software Project Estimation
Work Breakdown Structure
Software Team Characteristics, Organization, and Staffing
Reliable Estimations of Software Development
Estimation Models
Estimation Methods
Estimation Model and Methods: Conclusions
Function Point Analysis
5. The Software Quality Assurance Program: Project Software Documentation
Software Planning Documents
Software Requirements and Design Documents
Software Testing and Verification and Validation Documents
Software Documentation Usage
6. The Software Quality Assurance Program: Software Development Activities
Software Requirements Engineering
Quality Function Deployment in Software
Heuristics, Rigor, and Cost in Software Design
Software Requirements versus Software Design
The Software Life Cycle in Practice
Prototypes
Software Reviews
Software Reuse
The Software Postmortem
7. The Software Quality Assurance Program: Software Testing Activities
Software Nodes and Paths
Stress and Boundary Tests
Software Testing Strategy
Selection of Orthogonal Array Testing
Unit and Module Testing
Static Testing
Integration Testing
Validation Testing
Device System Testing
Software Safety Testing
Allocation of Software Testing
Software Reliability Engineered Testing
Software Statistical-Based Testing
Designing an Integrated Corporate Test Strategy
When is “Good Enough” Good Enough Testing?
The Last Test
8. The Software Quality Assurance Program: Software Verification and Validation Activities
Verification and Validation in the Software Life Cycle
Quality Assurance
Attributes of Quality Software
Attributes of Quality Software Specifications
Verification and Validation of Off-the-Shelf Software
Verification and Validation of Software Safety
Management Interface
9. The Software Quality Assurance Program: Software Configuration Management Activities
Baselines
Code Control
Firmware
Configuration Management
Control of Installed Variants
10. The Software Quality Assurance Program: Software Hazards and Safety Activities
Risk Management
Hazard Analysis
Hazard Analysis Models and Techniques
Hazard Analysis Difficulties
Safety
Reliability versus Safety
Software Safety
User Interface and Safety
11. The Software Quality Assurance Program: Software User Interface Activities
The Ubiquitous User Interface
What Is Usability?
Developing Human-Computer Interaction
Behavioral and Constructional Domains
Roles in User Interface Development
The Value of User-friendly Medical Device Interfaces
A Life Cycle for User Interaction Development
A Different Perspective of Noninterface Software Development
User Interface Development
Integration of Development Processes
12. The Software Quality Assurance Program: Software Metrics
Software Metrics and Models
Software Size Metrics
Data Structure Metrics
Logic Structure Metrics
Composite Metrics
Software Defects
Software Defect Models
Software Reliability and Reliability Growth Models
Maintainability Metrics Models
Software Statistical Process Control
Decision Making with Metrics
13. The Software Quality Assurance Program: Productivity and Capability Maturity Measurement
Overview of Software Process Improvement Measurement
Productivity Differentials in Software
Software Assessment Standards and Models
Software Metrics and Process Maturity
The Steps in Using Maturity Metrics
Identifying and Managing Risks for Software Process Improvement
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Tags: Steven Mallory, Software Development, Quality Assurance, Healthcare Manufacturing