Medical Device Quality Management Systems

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 System

Presents a roadmap for QMS development

Covers techniques to assess current state

Includes discussions on tools, such as CAPA and Six Sigma that help define vision, strategy and quality plans