Medical Device Quality Management Systems
Strategy and Techniques for Improving Efficiency and Effectiveness
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Product details:
- Publisher Elsevier Science
- Date of Publication 2 October 2018
- ISBN 9780128142219
- Binding Paperback
- No. of pages294 pages
- Size 234x190 mm
- Weight 540 g
- Language English 0
Categories
Long 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.
MoreTable of Contents:
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
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