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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.
 

Quality Assurance Associate

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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

Step 2

Course Title Click on a title to view course descriptionStatusDurationBasicPremiumPurchase
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
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
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 - Medical Devices Quality Management Systems Requirements for Regulatory PurposesRecommended183 mins€ 366.00€ 275.00
Introduction to Good Clinical PracticeRecommended45 mins€ 90.00€ 68.00
Good Laboratory Practices & Biological Evaluation for Medical DevicesRecommended70 mins€ 213.00€ 160.00
Introduction to Process ValidationRecommended75 mins€ 221.00€ 166.00

Step 3

Course Title Click on a title to view course descriptionStatusDurationBasicPremiumPurchase
Role of RA Specialist in the Design ProcessRecommended40 mins€ 118.00€ 89.00
Active Medical Devices in Europe: Particular RequirementsRecommended58 mins€ 177.00€ 133.00
The Australian Regulatory System for Medical DevicesRecommended110 mins€ 325.00€ 244.00
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
Overview of US FDA Quality System RegulationRecommended75 mins€ 300.00€ 225.00
History of Good Clinical Practice (GCP)Recommended15 minsFREEFREE
ISO 14155: 2011 – A Summary ReviewRecommended44 mins€ 134.00€ 100.00
Clinical Evaluation of Medical Devices: an IntroductionRecommended43 mins€ 127.00€ 95.00

Step 4

Course Title Click on a title to view course descriptionStatusDurationBasicPremiumPurchase
Pathways to CE Marking under the In Vitro Diagnostics DirectiveRecommended50 mins€ 148.00€ 111.00
The Draft European IVD Regulation50 mins€ 152.00€ 114.00
The Australian Regulatory System for In-Vitro Diagnostic (IVD) Devices80 mins€ 390.00€ 293.00