Main description:

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.

Contents:

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