Practical Design Control Implementation for Medical Devices Justiniano Jose
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…
Specifikacia Practical Design Control Implementation for Medical Devices Justiniano Jose
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