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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.

Pre-Clinical Study 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
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
Pathways to CE Marking under the In Vitro Diagnostics DirectiveRecommended50 mins€ 148.00€ 111.00
Regulatory Framework for In-Vitro Medical Devices in the USRecommended60 mins€ 177.00€ 133.00
Good Laboratory Practices & Biological Evaluation for Medical DevicesRecommended70 mins€ 213.00€ 160.00
Introduction to Process ValidationRecommended75 mins€ 221.00€ 166.00

Step 2

Course Title Click on a title to view course descriptionStatusDurationBasicPremiumPurchase
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
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
Biological Evaluation of Medical Devices: A Risk-Based ApproachRecommended63 mins€ 186.00€ 144.00
Importance of Technical Standards in the Medical Device SectorRecommended72 mins€ 213.00€ 159.00
Overview of US FDA Quality System RegulationRecommended75 mins€ 300.00€ 225.00
Project Management of Medical Device DevelopmentRecommended85 mins€ 340.00€ 255.00

Step 3

Course Title Click on a title to view course descriptionStatusDurationBasicPremiumPurchase
Active Medical Devices in Europe: Particular RequirementsRecommended58 mins€ 177.00€ 133.00
Standalone Software Under the Medical Devices DirectivesRecommended40 mins€ 160.00€ 120.00
The Draft European IVD Regulation50 mins€ 152.00€ 114.00
Understanding Software ValidationRecommended54 mins€ 216.00€ 162.00
Validating Software used in Company ProcessesRecommended65 mins€ 260.00€ 195.00
Imaging Modalities Used in Pre-Clinical ResearchRecommended62 mins€ 248.00€ 186.00
GHTF/IMDRF: Summary Technical Documentation (STED) and Its ContentsRecommended50 mins€ 148.00€ 111.00