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ID: 56654454

34 minutes

2 trainings

Trainings
Course ID Duration Price

with video

56654 14 minutes € 22.00
€ 22.00
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wmdos-34

654165415 20 minutes € 20.00
€ 20.00
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ID: NERW

25 minutes

1 modules

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

ID: 654165415

20 minutes

1 modules

only for test purposes

ID: 46485484

45 minutes

1 modules

Quality Assurance
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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ID: N58

265 minutes

7 trainings

Clinical Evaluation
Trainings
Course ID Duration Price

ISO 14155_课程1_范围

N213 40 minutes € 143.00
€ 143.00
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ISO 14155_课程2_伦理和知情同意

N214 30 minutes € 108.00
€ 108.00
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ISO 14155_课程3_临床试验策划

N215 50 minutes € 180.00
€ 180.00
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ISO 14155_课程4_临床试验的开展

N216 40 minutes € 143.00
€ 143.00
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ISO 14155_课程5_临床试验关闭

N217 25 minutes € 90.00
€ 90.00
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ISO 14155_课程6_申办方职责

N218 45 minutes € 161.00
€ 161.00
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ISO 14155_课程7_主要研究者职责

N219 35 minutes € 125.00
€ 125.00
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Manufacturers planning to market their devices in Europe are now required to furnish clinical data in line with the new European Directives that came into effect as of March 21, 2010. Read more

ID: 125

80 minutes

1 trainings

Clinical Evaluation
Trainings
Course ID Duration Price

Clinical Evaluation for Market Approval

116 80 minutes € 352.00
€ 352.00
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本套课程一共6课时,可向研究者和临床试验中心人员提供全面的医疗器械法规环境介绍以及每个研究者在决定是否参与医疗器械临床试验时需要考虑的要点。 您将可以学习相关的伦理和合法要求,如何确保试验的成功启动,在临床试验期间如何与申办方进行有效的合作以及关闭临床试验的要求。 本套课程中的部分内容来源于:... Read more

ID: N60

213 minutes

6 trainings

Clinical Evaluation
Trainings
Course ID Duration Price

课程1:医疗器械简介

N205 52 minutes € 120.00
€ 120.00
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如何进行医疗器械临床试验相关资质评估

N206 32 minutes € 95.00
€ 95.00
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医疗器械临床试验伦理和合法流程

N209 25 minutes € 84.00
€ 84.00
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临床试验的启动

N207 30 minutes € 95.00
€ 95.00
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临床试验开展与报告

N210 51 minutes € 128.00
€ 128.00
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临床试验关闭或终止

N208 23 minutes € 66.00
€ 66.00
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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: 187

213 minutes

6 trainings

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

Certification Programs
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 suite provides detailed information on the 2 major components of clinical evaluation through existing data and prospective clinical investi... Read more

ID: 123

70 minutes

1 trainings

Regulatory Affairs
Trainings
Course ID Duration Price

Clinical Evaluation Report: Review for Regulatory Professionals

107 70 minutes € 308.00
€ 308.00
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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

677 minutes

16 trainings

Clinical Evaluation
Trainings
Course ID Duration Price

History of Good Clinical Practice (GCP)

41 15 minutes Free Learn more

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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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: N41

265 minutes

7 trainings

Clinical Evaluation
Trainings
Course ID Duration Price

ISO 14155:2020 - Scope

N158 40 minutes € 143.00
€ 143.00
Add to Cart

ISO 14155:2020 - Ethical Considerations

N175 30 minutes € 108.00
€ 108.00
Add to Cart

ISO 14155:2020 - Clinical Investigation Planning

N176 50 minutes € 180.00
€ 180.00
Add to Cart

ISO 14155:2020 - Clinical Investigation Conduct

N177 40 minutes € 143.00
€ 143.00
Add to Cart

ISO 14155:2020 - Clinical Investigation Close Out

N178 25 minutes € 90.00
€ 90.00
Add to Cart

ISO 14155:2020 - Responsibilities of Sponsor

N184 45 minutes € 161.00
€ 161.00
Add to Cart

ISO 14155:2020 - Responsibilities of Principal Investigator

N185 35 minutes € 125.00
€ 125.00
Add to Cart
This 11-part course covers all aspects of the EU MDR 2017/745 in a comprehensive manner, providing practical guidance and identifying major differences with the current MDD/AIMD on the following to... Read more

ID: N180

330 minutes

7 modules

Regulatory Affairs
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
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 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
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 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 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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