Freshly Printed - allow 10 days lead
Couldn't load pickup availability
Medical Device Quality Management Systems
Strategy and Techniques for Improving Efficiency and Effectiveness
Teaches readers how to create a vision, strategy, and tactical plan for a Quality Management System for Medical Devices
Susanne Manz (Author)
9780128142219, Elsevier Science
Paperback, published 2 October 2018
294 pages
23.4 x 19 x 1.9 cm, 0.54 kg
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.
Part 1: An Effective Quality System1. Regulatory requirements 2. Increasing Expectations3. Establish and Maintain4. QMS Structure Part 2: An Efficient Quality Management System5. Shifting from Cost of Quality to Value of Quality6. Avoiding Common mistakes Part 3: Roles, Responsibilities, Capabilities7. Quality is Not an Organization8. Roles: Management Representative9. Management with Executive Responsibility10. Process Ownership11. Capabilities:Measure – Metrics and DashboardsEmbrace- Culture and ValueIdentify – Inspection, Audit, Process Control, etc.Fix – CAPA, Six Sigma, and morePrioritize – Risk Management, Residual RiskControl – Monitor and ControlShare and Communicate – Management Review and Transparency Part 4: Quality Leadership and a Seat at the Table12. Value of Quality13. Maturity Modeling in Medical Device Companies Part 5: Vision, Strategy, Quality Planning14. Compelling Vision15. Alignment16. Translating vision to plans Part 6: Improvement: Tools and Techniques17. CAPA18. Six Sigma
Subject Areas: Biomedical engineering [MQW]
