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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 Compliance Manager

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Step 1

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
Complaint Handling and Reporting Process for Medical DevicesRecommended65 mins€ 192.00€ 144.00
Deviations and Non-Compliance HandlingRecommended15 mins€ 44.00€ 33.00
Good Documentation Practices for Clinical Study FilesRecommended45 mins€ 133.00€ 100.00
Importance of Clinical Investigator´s Brochure (IB)Recommended85 mins€ 332.00€ 249.00
Clinical Events Committee (CEC) EstablishmentRecommended90 mins€ 360.00€ 270.00
Data Safety & Monitoring Board (DSMB) EstablishmentRecommended90 mins€ 360.00€ 270.00

Step 2

Course Title Click on a title to view course descriptionStatusDurationBasicPremiumPurchase
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 - 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
ISO 14155:2011- ScopeRecommended20 mins€ 61.00€ 46.00

Step 3

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
ISO 13485:2016 - Medical Devices Quality Management Systems Requirements for Regulatory PurposesRecommended183 mins€ 366.00€ 275.00
ISO 14971: 2007 ReviewRecommended35 mins€ 107.00€ 80.00
Preparing Risk Management File & Which Techniques ApplyRecommended24 mins€ 73.00€ 55.00
Integrating Risk Management into Your Quality Management SystemRecommended35 mins€ 107.00€ 80.00

Step 4

Course Title Click on a title to view course descriptionStatusDurationBasicPremiumPurchase
Introduction to Combination Products in the USRecommended62 mins€ 242.00€ 182.00
Introduction to Drug-Device Combination Regulations in EuropeRecommended55 mins€ 162.00€ 122.00
Labeling Requirements for Medical Devices in EuropeRecommended87 mins€ 257.00€ 193.00
Labeling Requirements for Medical Devices in the USRecommended70 mins€ 207.00€ 155.00
The European Union Regulatory System for Medical DevicesRecommended175 mins€ 517.00€ 388.00
Importance of Technical Standards in the Medical Device SectorRecommended72 mins€ 213.00€ 159.00

Step 5

Course Title Click on a title to view course descriptionStatusDurationBasicPremiumPurchase
Clinical Audits: Fundamentals of Auditing Medical Device Clinical InvestigationsRecommended36 mins€ 110.00€ 82.00
Clinical Audits: Sponsor/Third Party Audits of Clinical Investigation sitesRecommended66 mins€ 201.00€ 151.00
Clinical Audits: Auditing the Clinical Research Organisation and the SponsorRecommended82 mins€ 250.00€ 187.00
Preparing Successfully for a US FDA Medical Device InspectionRecommended109 mins€ 332.00€ 249.00

Step 6

Course Title Click on a title to view course descriptionStatusDurationBasicPremiumPurchase
Internal Auditor Training for Medical Device ManufacturersRecommended214 mins€ 652.00€ 489.00