Medical Device Quality Management Systems

<p>Part 1: An Effective Quality System1. Regulatory requirements 2. Increasing Expectations3. Establish and Maintain4. QMS Structure</p> <p>Part 2: An Efficient Quality Management System5. Shifting from Cost of Quality to Value of Quality6. Avoiding Common mistakes</p> <p>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</p> <p>Part 4: Quality Leadership and a Seat at the Table12. Value of Quality13. Maturity Modeling in Medical Device Companies</p> <p>Part 5: Vision, Strategy, Quality Planning14. Compelling Vision15. Alignment16. Translating vision to plans</p> <p>Part 6: Improvement: Tools and Techniques17. CAPA18. Six Sigma</p>