Reliable Design of Medical Devices leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.

Features:

• Provides a roadmap to improved reliability at all stages of medical device design
• Considers the many facets of medical device design: regulatory, standardization, legal, and technical
• Aids the implementation of a reliability engineering program while helping buyers perform better vendor evaluations
• Includes new chapters on quality system regulation and Six Sigma for design
• Discusses new topics such as CAD/CAM, material selection and biocompatibility, rapid prototyping, and availability

Contents

Basics of Reliability

• Reliability
• The Concept of Failure

Regulations and Standards

• The Food and Drug Administration
• The Medical Device Directives
• Quality System Regulation
• Domestic Standards
• International Standards

Specifiying 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 Processes

• GMPs and Manufacturing
• Configuration Management
• Analysis of Field Data

Index

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