Medical Device Regulatory Affairs: Global Quality Management Systems, the Requirements
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This program is currently unavailable for enrollment.
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Check for newer version in our catalog.
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Free Trial CoursesOutline:INTRODUCTION 1. Welcome 2. Introduction 3. Assessment THE STANDARD 4. Why Use ISO13485:2003? 5. Applying ISO13485:2003 6. Defining A QMS 7. Review THE QMS 8. Introduction 9. Key Areas Of The QMS 10. ISO9000 Vs ISO13485 11. Resource Management 12. Product Realization 13. Planning For Product Realization 14. Customer-Related Processes 15. Design & Development 16. Purchasing & Vendor Assurance 17. Production & Service Provision 18. Control Of Production Processes ANALYSIS, IMPROVEMENT & DOCUMENTS 19. Measurement & Analysis I 20. Measurement & Analysis II 21. Measurement & Analysis III 22. Improvement 23. QMS Documentation 24. Company Responsibilities 25. Review I 26. Review II CERTIFYING THE QMS 27. Iso 13485 Certification 28. What To Expect During An Audit 29. Review CONCLUSION 30. Summary GLOSSARY/RESOURCES | Objectives:State how ISO 13485:2003 relates to the medical device industry Identify the key areas of and resources needed for the Quality Management System (QMS) Identify some key roles in administration of the QMS Recognize how the QMS is to be certified by an external auditing authority. | |
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