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Tuesday, June 15, 2021
Home » Medical Device Regulatory Affairs: US Overview

Medical Device Regulatory Affairs: US Overview (MDU1)

Certification Training
 
Rated 3.67/5
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Method of Training: Online / Self-paced eLearning.
Credit Hours: 1 credits.
Duration: ~1 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

THIS COURSE IS CURRENTLY NOT AVAILABLE.
Contact the Biopharma Institute for more information.

COURSE OUTLINE:


INTRODUCTION
1. Welcome
2. Introduction
3. Reviews and Assessment

OVERVIEW OF THE USA REGULATORY SYSTEM
4. USA Medical Device Industry
5. Medical Device Definition
6. The Food & Drug Administration (FDA)
7. Historical Perspective
8. Regulations
9. Review

CLASSIFICATION SYSTEM AND REGULATORY CONTROL
10. Medical Device Classification
11. Important Terminology
12. Example
13. Regulatory Control and Classification
14. General Controls
15. Special Controls
16. Premarket Approval
17. Classifications and Exemptions
18. Special Considerations
19. Review

CONCLUSION
20. Summary

COURSE OBJECTIVES:


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