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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.
 

Marketing Manager

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Step 1

Course Title Click on a title to view course descriptionStatusDurationBasicPremiumPurchase
The Lifecycle of Medical Devices from Idea to MarketRecommended42 mins€ 124.00€ 93.00
Business Plan Essentials for Medical ProductsRecommended60 mins€ 246.00€ 184.00
Creating Value in HealthcareRecommended44 mins€ 172.00€ 129.00
GHTF/IMDRF – Essential Principles of Safety and Performance for Medical DevicesRecommended83 mins€ 245.00€ 184.00
Introduction to the GHTF or IMDRFRecommended25 mins€ 74.00€ 55.00
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

Step 2

Course Title Click on a title to view course descriptionStatusDurationBasicPremiumPurchase
Clinical Data for ReimbursementRecommended57 mins€ 233.00€ 175.00
Introduction to the EU Regulatory SystemRecommended36 mins€ 106.00€ 80.00
Introduction to the US FDARecommended25 minsFREEFREE
Steps to CE MarkRecommended52 mins€ 154.00€ 115.00
The Main Concepts for Safe and Performing DevicesRecommended39 mins€ 115.00€ 86.00
ISO 14971: 2007 ReviewRecommended35 mins€ 107.00€ 80.00
Post Market Surveillance: an IntroductionRecommended34 mins€ 100.00€ 75.00
Complaint Handling and Reporting Process for Medical DevicesRecommended65 mins€ 192.00€ 144.00
Introduction to Digital Governance: A Four-Step ApproachRecommended57 mins€ 168.00€ 126.00

Step 3

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

Step 4

Course Title Click on a title to view course descriptionStatusDurationBasicPremiumPurchase
History of Good Clinical Practice (GCP)Recommended15 minsFREEFREE
Introduction to Good Clinical PracticeRecommended45 mins€ 90.00€ 68.00
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
The Informed Consent ProcessRecommended45 mins€ 133.00€ 100.00
Ethics Committee(EC) / Institutional Review Board RequirementsRecommended40 mins€ 118.00€ 89.00
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
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 14155: 2011 – A Summary ReviewRecommended44 mins€ 134.00€ 100.00
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
Clinical Evaluation of Medical Devices: an IntroductionRecommended43 mins€ 127.00€ 95.00

Step 5

Course Title Click on a title to view course descriptionStatusDurationBasicPremiumPurchase
Overview of US FDA Quality System RegulationRecommended75 mins€ 300.00€ 225.00
Electronic Instructions for Use of Medical Devices in the European UnionRecommended50 mins€ 152.00€ 114.00
ISO 13485 - Medical Devices Quality Management Systems Requirements for Regulatory PurposesRecommended183 mins€ 366.00€ 275.00
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

Step 6

Course Title Click on a title to view course descriptionStatusDurationBasicPremiumPurchase
IVD Australia: Basics for including an IVD on the ARTG44 mins€ 176.00€ 132.00
IVD Australia: Fees for Including an IVD Device on the TGA or ARTG43 mins€ 172.00€ 129.00
IVD Australia: Making Applications for Inclusion on the ARTG33 mins€ 132.00€ 99.00
IVD Australia: Obtaining a TGA Conformity Assessment Certificate for IVD devices40 mins€ 160.00€ 120.00
IVD Australia: The Use of GMDN Codes for IVDs in Australia45 mins€ 180.00€ 135.00