Managers in the medical device industries has gone beyond serving mainly as documentation watchdogs to linking changes in complex manufacturing specifications with customer and Food and Drug Administration requirements, according to these medical product device experts. Atypically focusing on both design control and reliability engineering, they provide practical advise to managers and technical staff on design control implementation, reliability tools and techniques, the product and design development life cycle, and process and design validation. Includes further reading, technical appendices, and a glossary.