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Gain early insights into the anticipated ISO 14155 updates with our FREE SUMMARY presentation by Danielle Giroud. Read more

ID: N350

14 minutes

1 modules

Clinical Evaluation
The ISO 14155 standard provides crucial guidance and support to any party involved in a clinical investigation -primarily to Sponsors (including monitors) and investigators, but also ethics committ... Read more

ID: N62

265 minutes

7 trainings

Cross Functional
Trainings
Course ID Duration Price

ISO 14155:2020 - Scope

N158 40 minutes € 143.00
€ 143.00
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ISO 14155:2020 - Ethical Considerations

N175 30 minutes € 108.00
€ 108.00
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ISO 14155:2020 - Clinical Investigation Planning

N176 50 minutes € 180.00
€ 180.00
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ISO 14155:2020 - Clinical Investigation Conduct

N177 40 minutes € 143.00
€ 143.00
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ISO 14155:2020 - Clinical Investigation Close Out

N178 25 minutes € 90.00
€ 90.00
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ISO 14155:2020 - Responsibilities of Sponsor

N184 45 minutes € 161.00
€ 161.00
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ISO 14155:2020 - Responsibilities of Principal Investigator

N185 35 minutes € 125.00
€ 125.00
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This comprehensive, self-paced 18 course suite provides you with all the necessary information, requirements and guidelines you need, including practical skills and tools to successfully accomplish... Read more

ID: 57

747 minutes

18 trainings

Clinical Evaluation
Trainings
Course ID Duration Price

History of Good Clinical Practice (GCP)

41 15 minutes Free

Introduction to Good Clinical Practice

42 45 minutes € 109.00
€ 109.00
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Introduction to Medical Device and Clinical Investigation Planning

43 45 minutes € 161.00
€ 161.00
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The Clinical Investigation Plan

44 45 minutes € 161.00
€ 161.00
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The Informed Consent Process

45 45 minutes € 161.00
€ 161.00
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Ethics Committee(EC) / Institutional Review Board Requirements

46 40 minutes € 143.00
€ 143.00
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Selecting Investigation Sites

47 45 minutes € 161.00
€ 161.00
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Initiation Visit

48 45 minutes € 161.00
€ 161.00
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Adverse Event Processes

59 77 minutes € 275.00
€ 275.00
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The Periodic Monitoring Visit

56 120 minutes € 429.00
€ 429.00
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Device Accountability

50 20 minutes € 72.00
€ 72.00
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Deviations and Non-Compliance Handling

51 15 minutes € 54.00
€ 54.00
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Source Document Verification

52 30 minutes € 108.00
€ 108.00
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The Case Report Form Process

53 45 minutes € 161.00
€ 161.00
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Visit Report Writing

54 15 minutes € 54.00
€ 54.00
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The Close Down Visit

55 30 minutes € 108.00
€ 108.00
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Good Documentation Practices for Clinical Study Files

96 45 minutes € 161.00
€ 161.00
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Overview of Data Management Plan and Query Process

108 25 minutes € 81.00
€ 81.00
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This program provides investigators and clinical investigation site personnel with a comprehensive introduction to the medical device regulatory environment. Read more

ID: N43

213 minutes

6 trainings

Clinical Evaluation
This suite of 2 courses provides a review of the overall regulatory requirements in EU, US and JAPAN; which documents are applicable and what the different reporting requirements are for both compe... Read more

ID: 79

45 minutes

2 trainings

Clinical Evaluation
Trainings
Course ID Duration Price

US Safety Reporting Requirements during Pre-Market Clinical Trials

90 20 minutes € 72.00
€ 72.00
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European Safety Reporting Requirements during Clinical Investigations

82 25 minutes € 90.00
€ 90.00
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This course focuses on clinical Investigator’s Brochures (IBs) and offers key insight into the importance of providing investigators with information supporting a medical device’s use in clinical i... Read more

ID: 117

85 minutes

2 modules

Clinical Evaluation
This comprehensive review of the EU-MDR 2017-745 focusses on the particular parts of the regulation that need understanding and compliance by clinical professionals during the planning, execution a... Read more

ID: N249

80 minutes

2 modules

Clinical Evaluation
Manufacturers planning to market their devices in Europe are required to provide clinical data in line with the European Medical Device Regulation... Read more

ID: 116

80 minutes

2 modules

Clinical Evaluation
Untangle the mysteries about GDPR for medical device clinical investigations. The course provides a detailed review of the GDPR requirements and how these apply to medical device investigations. Read more

ID: N246

37 minutes

2 modules

Clinical Evaluation
This course provides a condensed yet inclusive summary review of the latest version of the ISO 14155  standard. It covers the following topics:... Read more

ID: 144

80 minutes

2 modules

Clinical Evaluation
This short course will walk you through the various GCP regulatory documents applied in different parts of the world, starting with an introduction to ISO 14155. Read more

ID: N325

45 minutes

2 modules

Clinical Evaluation
The course provides detailed insight into clinical evaluation report reviews by Notified Body and Regulatory reviewers. Read more

ID: 107

70 minutes

2 modules

Regulatory Affairs
This course outlines the major international legal data protection backgrounds and how they apply to post-market clinical investigations of medical devices. Read more

ID: 226

31 minutes

2 modules

Clinical Evaluation

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