The second edition of this practical guide presents the basic concepts and the major issues involved in the design of medical devices, updating the information to stay at the forefront of developments in the industry. The book begins with a rigorous definition of reliabilty, differentiating it from quality, and exploring the many aspects of failure in detail. It examines domestic and international regulations and standards. New topics in this edition include Six Sigma philosophy, electronic signature, material selection and biocompatibility, quick response manufacturing, and quality system regulation.

From the Preface: “...Medical device development is therefore a complex process that requires the careful integration of diverse disciplines, technical activities, standards, regulatory requirements, and administrative project controls. The need for systematic approaches to product development and maintenance is necessary to ensure a safe and effective device for the user and patient, an economical and competitive success for the manufacturer, and a reliable, cost-effective investment for the user...The primary goal of this text is to acquaint the developer of medical devices, as well as the purchaser of medical equipment, with the basic concepts and major issues of medical device reliability, to describe current product development processes and techniques, and to provide a basis for evaluating new technologies...”

Target Audience: Designers, plant managers, process and quality engineers, and production managers in medical device companies.

Table of Contents:

Basics of Reliability:

Reliability

The Concept of Failure

Regulations and Standards:

The Food and Drug Administration

The Medical Devices Directives

Quality System Regulation

Domestic Standards

International Standards

Specifying the Product:

The Medical Device As an Entity

Defining the Device

Requirements Engineering

Safety and Risk Management

Liability

Intellectual Property

Designing the Product:

Six Sigma and Product Design

Hardware Design

Software Design

Software Coding

Establishing and Using Metrics

Human Factors

Testing and Data Analysis:

The Basis and Types of Testing

Hardware Verification and Validation

Software Verification and Validation

Analysis of Test Results

The Manufacturing and Maintenance Process:

GMPs and Manufacturing

Configuration Management

Analysis of Field Data

Appendices

Index