Practical Design Control Implementation for Medical Devices

" Provides a macro view of what it takes to develop and design medical devices in accordance with the Quality System Regulation
" Defines the practical implementation aspects of design control guidelines so that products can meet and exceed regulatory requirements, including the FDA's Quality System Regulation
" Explains device reliability engineering tools and techniques for successful implementation of design control and reliability engineering
" Presents easy-to-understand examples of typical product design and development phases with corresponding reliability tools such as failure modes and effects analysis
" Covers both strategic and tactical implementation of design control for medical device design

Bringing together, for the first time, the concepts of design control and reliability engineering, Practical Design Control Implementation helps you face the challenge of designing and developing products that comply with regulatory requirements and fulfill customer expectations. Written with all levels of management and technical personnel in mind, the authors demonstrate how successful design control implementation can result in fewer customer complaints and medical device reports, more satisfied customers, and faster time-to-market.

Part One focuses on the practical aspects of design control implementation for medical devices. The fundamental concepts of design control are not new. What is new is the adoption by the FDA of these principles and their consequent enforcement. Also new to the medical device industry are the different technical concepts, tools, and techniques necessary to implement design control. In this section, each chapter provides practical advice and insight on the required FDA design control elements.

Part Two explores the reliability of medical devices and how design control can influence that reliability. The book presents easy to understand examples of typical product design and development phases with the corresponding reliability and risk analysis tools such as failure modes and effects analysis (FMEA), hazard analysis, reliability planning, reliability prediction, design verification, and validation. The authors discuss the inter-relatedness of reliability engineering and design control and apply the concept to medical device design.

Providing common sense explanations and guidance, Practical Design Control Implementation helps readers successfully execute design control and reliability engineering procedures that not only meet the FDA guidelines but also meet or exceed customer expectations.