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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.
 

Regulator

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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
Introduction to the GHTF or IMDRFRecommended25 mins€ 74.00€ 55.00
GHTF/IMDRF: The Pre-Market ModelRecommended30 mins€ 89.00€ 66.00
GHTF/IMDRF – The Post-Market ModelRecommended30 mins€ 89.00€ 66.00
GHTF/IMDRF – Supporting DocumentsRecommended30 mins€ 89.00€ 66.00
GHTF/IMDRF – International ImplementationRecommended35 mins€ 103.00€ 78.00
GHTF/IMDRF – Essential Principles of Safety and Performance for Medical DevicesRecommended83 mins€ 245.00€ 184.00
GHTF/IMDRF: Summary Technical Documentation (STED) and Its ContentsRecommended50 mins€ 148.00€ 111.00
Complaint Handling and Reporting Process for Medical DevicesRecommended65 mins€ 192.00€ 144.00
Good Documentation & Writing Practices for Regulatory SubmissionsRecommended60 mins€ 234.00€ 176.00
Role of RA Specialist in the Design ProcessRecommended40 mins€ 118.00€ 89.00
Importance of Technical Standards in the Medical Device SectorRecommended72 mins€ 213.00€ 159.00
ISO 14971: 2007 ReviewRecommended35 mins€ 107.00€ 80.00
Preparing Risk Management File & Which Techniques ApplyRecommended24 mins€ 73.00€ 55.00
Clinical Evaluation of Medical Devices: an IntroductionRecommended43 mins€ 127.00€ 95.00
The European Union Regulatory System for Medical DevicesRecommended175 mins€ 517.00€ 388.00
Introduction to Drug-Device Combination Regulations in EuropeRecommended55 mins€ 162.00€ 122.00
Demarcation of Medical Devices to Other ProductsRecommended60 mins€ 177.00€ 133.00
Active Medical Devices in Europe: Particular RequirementsRecommended58 mins€ 177.00€ 133.00
ISO 13485:2016 - Medical Devices Quality Management Systems Requirements for Regulatory PurposesRecommended183 mins€ 366.00€ 275.00
How to Navigate Through the ISO 13485 Certification ProcessRecommended44 mins€ 176.00€ 132.00
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
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
Biological Evaluation of Medical Devices: A Risk-Based ApproachRecommended63 mins€ 186.00€ 144.00
Pathways to CE Marking under the In Vitro Diagnostics DirectiveRecommended50 mins€ 148.00€ 111.00
The Draft European IVD RegulationRecommended50 mins€ 152.00€ 114.00
History of Good Clinical Practice (GCP)Recommended15 minsFREEFREE
Introduction to Good Clinical PracticeRecommended45 mins€ 90.00€ 68.00
CPM: Objectives and Setup of a Medical Device Clinical TrialRecommended35 mins€ 160.00€ 120.00
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
ISO 14155: 2011 – A Summary ReviewRecommended44 mins€ 134.00€ 100.00
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 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
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