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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.
 

Regulatory Affairs Manager

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Step 1

Course Title Click on a title to view course descriptionStatusDurationBasicPremiumPurchase
How to Navigate Through the ISO 13485 Certification ProcessRecommended44 mins€ 176.00€ 132.00
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
Labeling Requirements for Medical Devices in EuropeRecommended87 mins€ 257.00€ 193.00
Electronic Instructions for Use of Medical Devices in the European UnionRecommended50 mins€ 152.00€ 114.00
Biological Evaluation of Medical Devices: A Risk-Based ApproachRecommended63 mins€ 186.00€ 144.00
Overview of US FDA Quality System RegulationRecommended75 mins€ 300.00€ 225.00
Project Management of Medical Device DevelopmentRecommended85 mins€ 340.00€ 255.00
Preparing Successfully for a US FDA Medical Device InspectionRecommended109 mins€ 332.00€ 249.00
Powerful Presentation SkillsRecommended140 mins€ 267.00€ 200.00
Team BuildingRecommended100 mins€ 390.00€ 293.00

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
Clinical Data for ReimbursementRecommended57 mins€ 233.00€ 175.00
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
The Informed Consent ProcessRecommended45 mins€ 133.00€ 100.00
Ethics Committee(EC) / Institutional Review Board RequirementsRecommended40 mins€ 118.00€ 89.00

Step 3

Course Title Click on a title to view course descriptionStatusDurationBasicPremiumPurchase
Clinical Evaluation report of Existing data for CE-mark: review for regulatory professionalsRecommended70 mins€ 280.00€ 210.00
Data from Prospective Clinical Investigation for CE-Mark: Review for Regulatory ProfessionalsRecommended95 mins€ 380.00€ 285.00
Clinical Evaluation for EU Market Approval: Literature ReviewRecommended50 mins€ 205.00€ 154.00
Performing a Clinical Evaluation for EU Market Approval: Step by Step PrimerRecommended58 mins€ 238.00€ 178.00
Designing a Strategic Medical Device Clinical Investigation Plan/ProtocolRecommended90 mins€ 454.00€ 341.00
Format and Structure of a Medical Device Clinical Investigation Plan/ProtocolRecommended42 mins€ 132.00€ 99.00
Clinical Protocol Writing Process and Ensuring ComplianceRecommended35 mins€ 110.00€ 83.00

Step 4

Course Title Click on a title to view course descriptionStatusDurationBasicPremiumPurchase
The Australian Regulatory System for In-Vitro Diagnostic (IVD) DevicesRecommended80 mins€ 390.00€ 293.00
IVD Australia: Basics for including an IVD on the ARTGRecommended44 mins€ 176.00€ 132.00
IVD Australia: The Use of GMDN Codes for IVDs in AustraliaRecommended45 mins€ 180.00€ 135.00
IVD Australia: Making Applications for Inclusion on the ARTGRecommended33 mins€ 132.00€ 99.00
IVD Australia: Obtaining a TGA Conformity Assessment Certificate for IVD devicesRecommended40 mins€ 160.00€ 120.00
IVD Australia: Fees for Including an IVD Device on the TGA or ARTGRecommended43 mins€ 172.00€ 129.00

Step 5

Course Title Click on a title to view course descriptionStatusDurationBasicPremiumPurchase
Health Economic Evaluation of Medical TechnologiesRecommended65 mins€ 322.00€ 241.00
Reimbursement Strategy for Medical Devices in the USRecommended45 mins€ 86.00€ 64.00
The Basics of US Private Payer Reimbursement for Medical DevicesRecommended32 mins€ 64.00€ 48.00