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

Medical Device Quality Management Systems has been written with the needs of quality, compliance, and regulatory professionals in medical device companies in mind.  In this book Susanne Manz shares lessons learned from over 30 years of experience in the medical device industry.  She shares secrets for developing an effective yet efficient Quality Management System (QMS) for medical device companies.  This book is for anyone that feels frustrated by books that provide information on what must be accomplished in a QMS, but very little information on how to do it.  Medical Device Quality Management Systems explains how to create a vision, strategy, and tactical plans for a QMS.

Manz shares lessons on leadership and key roles and responsibilities within a medical device company.  Good quality and compliance results depend on all individuals and functions in an organization.  The “Management Representative” and “Management with Executive Responsibility” are critical roles.  This book provides context and guidance for those individuals.   Manz explores the concepts of process ownership, individual accountability, and a culture of quality and compliance.  This book is useful for all executive, functional leaders, and organizations to prepare them for working in the highly regulated medical device industry. Utilizing these concepts, a medical device company can make quality and compliance a competitive strength.

Provides practical, real-world guidance on developing an effective and efficient Quality Management SystemA roadmap for QMS developmentTechniques to assess your current stateTools such as CAPA and Six Sigma to define your vision, strategy, and quality plans

Part 1: An Effective Quality System 1. Regulatory requirements 2. Increasing Expectations 3. Establish and Maintain 4. QMS Structure

Part 2: An Efficient Quality Management System 5. Shifting from Cost of Quality to Value of Quality 6. Avoiding Common mistakes

Part 3:  Roles, Responsibilities, Capabilities 7. Quality is Not an Organization 8. Roles: Management Representative 9. Management with Executive Responsibility 10. Process Ownership 11. Capabilities: Measure – Metrics and Dashboards Embrace- Culture and Value Identify – Inspection, Audit, Process Control, etc. Fix – CAPA, Six Sigma, and more Prioritize – Risk Management, Residual Risk Control – Monitor and Control Share and Communicate – Management Review and Transparency

Part 4:  Quality Leadership and a Seat at the Table 12. Value of Quality 13. Maturity Modeling in Medical Device Companies

Part 5:  Vision, Strategy, Quality Planning 14. Compelling Vision 15. Alignment 16. Translating vision to plans

Part 6:  Improvement: Tools and Techniques 17. CAPA 18. Six Sigma