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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.

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Step 1

Course Title Click on a title to view course descriptionStatusDurationBasicPremiumPurchase
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
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
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
Overview of US FDA Quality System RegulationRecommended75 mins€ 300.00€ 225.00
Preparing Successfully for a US FDA Medical Device InspectionRecommended109 mins€ 332.00€ 249.00

Step 2

Course Title Click on a title to view course descriptionStatusDurationBasicPremiumPurchase
Active Medical Devices in Europe: Particular RequirementsRecommended58 mins€ 177.00€ 133.00
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
Regulatory Framework for In-Vitro Medical Devices in the USRecommended60 mins€ 177.00€ 133.00

Step 3

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
The Hong Kong Regulatory System for Medical DevicesRecommended72 mins€ 213.00€ 159.00
Singapore’s Regulatory System for Medical DevicesRecommended68 mins€ 139.00€ 104.00
The Australian Regulatory System for Medical DevicesRecommended110 mins€ 325.00€ 244.00