ABSTRACT

As medical devices become even more intricate, concerns about efficacy, safety, and reliability continue to be raised. Users and patients both want the device to operate as specified, perform in a safe manner, and continue to perform over a long period of time without failure. Following in the footsteps of the bestselling second edition, Reliable D

chapter |20 pages

Contents

chapter |6 pages

Preface

chapter 1|12 pages

- Reliability

chapter 2|8 pages

- The Concept of Failure

chapter 4|16 pages

- Defining the Device

chapter 5|18 pages

- Safety and Risk Management

chapter 6|8 pages

- Documents and Deliverables

chapter 7|22 pages

- The FDA

chapter 8|22 pages

Human Factors

chapter 9|6 pages

- Important Medical Device Standards

chapter 10|28 pages

Requirements Engineering

chapter 11|14 pages

- Requirements Engineering

chapter 12|8 pages

- Liability

chapter 13|18 pages

- Intellectual Property

chapter 14|4 pages

- The Project Team

chapter 15|4 pages

- The Reliability Goal and Plan

chapter 16|4 pages

Hardware Risk Analysis

chapter 17|24 pages

- Hardware Design

chapter 18|18 pages

- Hardware Risk Analysis

chapter 19|6 pages

- Design and Project Metrics

chapter 20|20 pages

- Design for Six Sigma

chapter 21|14 pages

Software Metrics

chapter 22|12 pages

- Software Coding

part 23|2 pages

- Software Risk Analysis

chapter 24|18 pages

- Software Metrics

chapter 25|4 pages

- Documents and Deliverables

chapter 26|16 pages

- The Basis and Types of Testing

chapter 27|24 pages

- Hardware Verification and Validation

chapter 28|12 pages

- Hardware Data Analysis

chapter 29|10 pages

- Software Verification and Validation

chapter 30|10 pages

Software Manufacturing

chapter 31|4 pages

Documents and Deliverables

chapter 32|6 pages

Analysis of Field Data

chapter 33|8 pages

Monitored Activity

part 34|2 pages

- Software Manufacturing

chapter 35|8 pages

- Configuration Management

chapter 36|4 pages

- Documents and Deliverables

chapter 37|6 pages

- Analysis of Field Data

chapter 38|2 pages

- Monitored Activity