Medical Device Quality Management Systems

Strategy and Techniques for Improving Efficency and Effectiveness

​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 techniques 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 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 who want more information on how to create an effective and efficient Quality Management System.

Academic Press,
an Imprint of Elsevier

October 1, 2018

This book is for anyone who feels frustrated with books that provide information on what must be accomplished in a QMS, but very little information on how to do it.   This book explores what it means to "establish and maintain" a suitable and effective Quality Management System (QMS).

Part I covers the history of medical device regulation and how that shaped the regulations we know today.  Prior to regulation, products were frequently ineffective resulting in false hope and delays in proper treatment.  And at the other extreme, unregulated products were often addictive, harmful, or even deadly.  Con-men, quacks, and snake-oil salesmen used deceptive and misleading advertising techniques to deceive the public.  Over time, regulations were put in place to protect the public.  And the regulations continue to change even today. Expectations are ever-increasing as new products and technologies continue to change the medical device industry.  This book explores the details of current expectations to “establish and maintain” a suitable and effective quality management system that is compliant and results in improved product quality, providing safe and effective products.  “Establish and maintain” requires a process approach and a defined QMS structure. 

Part 2 explores the characteristics of an efficient quality management system as well as the relationship between efficiency and effectiveness. Of course, regulators and customers are concerned about quality system effectiveness.  But, employees and shareholders have a stake in quality system efficiency as well. 

Part 3 identifies and details the  key roles and responsibilities for creating an efficient and effective quality management system.  Quality is not an Organization!  Every individual in the organization is responsible for quality.  Key roles include management with executive responsibility, the management representative, process owners, and individual accountability.   These are entwined in the fabric of a culture of quality.   Part 3 also defines key capabilities or MEDICS essential for success.

Part 4 describes the role of the quality organization and how to bring value to the organization to earn a seat at the table.  Concepts of quality and compliance have developed significantly from early days of quality control and quality assurance.  World class quality and compliance requires that medical device companies have a system of intelligence to define, measure, and articulate quality and compliance risks and opportunities.  It is more common now for Quality, Compliance, and Regulatory leaders to have a seat at the table to bring this intelligence to the table.  Business success depends on analyzing, interpreting, and identifying global risks and leading risk reduction activities.  Quality and compliance leaders facilitate interpretation and translation of regulations and constantly changing expectations, identify and mitigate risk, and use quality as a key competitive differentiator.

Part 5 identifies steps to translate vision and quality objectives into improvement strategies and more detailed plans.  A quality system is a network of processes, people, and infrastructure that must work together in a cohesive, aligned manner to realize quality objectives.  An efficient and effective QMS takes on-going effort to look for signs of mis-alignment and take appropriate action to drive stakeholder alignment.

Part 6 provides an overview of critical improvement methodologies and tools, including corrective and preventive action (CAPA), root cause analysis (RCA), as well as inspection preparedness.

Academic Press
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