Medical Device Quality Management: Managing a QMS
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Download Thursday, June 11, 2026 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
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Free Trial CoursesOutline:INTRODUCTION 1. Welcome 2. Introduction 3. Reviews and assessments QUALITY MANAGEMENT SYSTEM OVERVIEW 4. Overview 5. Key QMS subsystems within ISO13485 6. Key QMS subsystems within CFR820 7. Regulatory requirements 8. Maintenance of a QMS 9. Topic review MANAGEMENT RESPONSIBILITY 10. Overview 11. Management compliance responsibility 12. Periodic management review 13. Overview of QMS roles and responsibilities 14. Management responsibilities 15. The management representative 16. Topic review QUALITY AUDITS 17. The role of audits in a QMS 18. Setting up an internal audit program 19. Key requirements for internal audits 20. The five steps of internal audits 21. Commitment tracking 22. Topic review MEASURING PERFORMANCE 23. Overview 24. Monitoring and measurement 25. Sources of data 26. Statistical techniques 27. Improvement 28. Topic review CONCLUSION 29. Summary GLOSSARY/RESOURCES | Objectives: | |
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