Medical Device Quality Management Systems —— Strategy and Techniques for Improving Efficiency and Effectiveness

----- 医疗器械质量管理体系：提高效率的战略和技术

ISBN: 9780128142219 出版年：2018 页码：298 Manz, Susanne Academic Press_RM

Medical Devices Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness is written for the needs of quality, compliance, and regulatory professionals in medical device companies. It includes secrets for developing an effective, yet efficient, Quality Management System (QMS) and explains how to create a vision, strategy, and tactical plans. Author Manz shares lessons on leadership, key roles and responsibilities within a medical device company, while also exploring the concepts of process ownership, individual accountability, and how to cultivate a culture of quality and compliance. This book is useful for all executive, functional leaders, and organizations in the highly regulated medical device industry.Provides practical, real-world guidance on developing an effective and efficient Quality Management SystemPresents a roadmap for QMS developmentCovers techniques to assess current stateIncludes discussions on tools, such as CAPA and Six Sigma that help define vision, strategy and quality plans