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The following curriculum of courses have been determined by WMDO experts to help you to reach your career objectives according to the position you have selected and are divided into sections which will allow you to follow the proposed training in an efficient and structured manner.

For this reason, we strongly recommend that you complete each section before moving along to the next.

You must be logged into your account in order to view your personal training progress in the results below.
 

Clinical Quality Associate

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Step 1

Course Title Click on a title to view course descriptionStatusDurationBasicPremiumPurchase
GHTF/IMDRF – Essential Principles of Safety and Performance for Medical DevicesRecommended83 mins€ 245.00€ 184.00
GHTF/IMDRF – International ImplementationRecommended35 mins€ 103.00€ 78.00
GHTF/IMDRF – Supporting DocumentsRecommended30 mins€ 89.00€ 66.00
GHTF/IMDRF – The Post-Market ModelRecommended30 mins€ 89.00€ 66.00
GHTF/IMDRF: The Pre-Market ModelRecommended30 mins€ 89.00€ 66.00
GHTF/IMDRF: Summary Technical Documentation (STED) and Its ContentsRecommended50 mins€ 148.00€ 111.00
Introduction to the GHTF or IMDRFRecommended25 mins€ 74.00€ 55.00
ISO 14155:2011 - Clinical Investigation Close OutRecommended20 mins€ 61.00€ 46.00
ISO 14155:2011 - Clinical Investigation ConductRecommended40 mins€ 122.00€ 91.00
ISO 14155:2011 - Clinical Investigation PlanningRecommended30 mins€ 61.00€ 46.00
ISO 14155:2011- ScopeRecommended20 mins€ 61.00€ 46.00
ISO 14155:2011 - Ethical ConsiderationsRecommended20 mins€ 61.00€ 46.00
ISO 14155:2011 - Responsibilities of Principal InvestigatorRecommended30 mins€ 91.00€ 69.00
ISO 14155:2011 - Responsibilities of SponsorRecommended45 mins€ 137.00€ 103.00
History of Good Clinical Practice (GCP)Recommended15 minsFREEFREE

Step 2

Course Title Click on a title to view course descriptionStatusDurationBasicPremiumPurchase
Adverse Event ProcessesRecommended77 mins€ 198.00€ 148.00
European Safety Reporting Requirements during Pre-Market clinical InvestigationsRecommended25 mins€ 74.00€ 55.00
US Safety Reporting Requirements during Pre-Market Clinical TrialsRecommended20 mins€ 59.00€ 44.00
Directive 93/42/EEC and update 2007/47/EC: A review for clinical professionals (rev 1.2)Recommended60 mins€ 183.00€ 137.00
US FDA Investigational Device Exemption (IDE) OverviewRecommended125 mins€ 381.00€ 286.00

Step 3

Course Title Click on a title to view course descriptionStatusDurationBasicPremiumPurchase
Deviations and Non-Compliance HandlingRecommended15 mins€ 44.00€ 33.00
Good Documentation Practices for Clinical Study FilesRecommended45 mins€ 133.00€ 100.00
Introduction to the US FDARecommended25 minsFREEFREE
IRB Review of Medical DevicesRecommended153 mins€ 452.00€ 339.00
The Informed Consent ProcessRecommended45 mins€ 133.00€ 100.00

Step 4

Course Title Click on a title to view course descriptionStatusDurationBasicPremiumPurchase
BIMO: US FDA BIMO Compliance ProgramRecommended54 mins€ 165.00€ 123.00
BIMO: IDE Sponsor ObligationsRecommended180 mins€ 549.00€ 411.00
BIMO: IDE Investigator ObligationsRecommended190 mins€ 594.00€ 446.00