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Medical Device Vigilance Course
1 Section
10 Lessons
4 Quizzes
3 Hours
Curriculum
1 Section
10 Lessons
3 Hours
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Week 1: Introduction to Medical Device Vigilance
14 Items
1.1
Medical Device & Classification
1.2
Global Medical Device Regulations
1.3
Fundamentals Of Medical Devices & Regulatory Warning Letters
1.4
Fundamentals of Medical Devices, Software in medical devices & Device Labelling
1.5
Regulatory pathways- 510(k) and PMS
0 Questions
1.6
Medical Device Post Market surveillance and Complaint Handling
0 Questions
1.7
Medical Device Post Market surveillance and Complaint Handling (Complaint vs Feedback vs Non-complaint)
0 Questions
1.8
mdv test
0 Questions
1.9
Medical Device Post Market surveillance and Complaint Handling (Complaint vs Feedback vs Non-complaint)
1.10
Complaint Intake/ triage process and practical scenarios
1.11
Complaint Evaluation Process and practical Examples.
1.12
Complaint Handling Global Decision tree process and initial report submission
1.13
Different regulatory reporting, Complaint Investigation, follow-up/final reporting and close complaints
1.14
Investigation related examples, follow-up/final reporting/close complaints and QA
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