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For designers of medical devices, the FDA and ISO requirements are extremely stringent. Designers and researchers feel pressure from management to quickly develop new devices, while they are simultaneously hampered by strict guidelines. The Six Sigma philosophy has solved this dichotomous paradigm for organizations in other fields, and seeks to do the same for the medical devices field.
Six Sigma for Medical Device Design is the first book to approach the subject for use in the medical device field. Authored by experienced professionals, it provides a how-to guide to implementing such a...

Art and the Artist in Society is a compilation of essays that examine the nexus between artists, the art they create and society. These essays consider how art has changed its form and role both to accommodate newer trends and to fully participate in society. Divided into six thematic sections, the book examines the works of a diverse group of artists working in a range of art forms, such as writers Milan Kundera and Judith Ortiz Cofer, filmmakers Humberto Solas and Walter Salles, performers/photographer Daniel Joseph Martinez and feminist-activists Suzanne Lacy and Leslie Labowitz. The...

Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements. Part One covers motivation for design control and validation, design control requirements, process validation and design transfer, quality system for design control, and measuring design control program effectiveness. Part Two discusses risk analysis and FMEA, designing-in reliability, reliability and design...