Online Course Catalogue

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Pre-Clinical

Basic Level : CMDA – Certified Medical Device Associate
Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
Biological Evaluation of Medical Devices: A Risk-Based Approach N13463 mins€ 205.00€ 158.00
Introduction to Process Validation N13575 mins€ 243.00€ 183.00
Validation of Ethylene Oxide Sterilization of Medical Devices N18653 mins€ 172.00€ 129.00

Pre-Clinical

Advanced Level : CMDP – Certified Medical Device Professional
Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
Biocompatibility of Medical Devices N18850 mins€ 166.00€ 125.00

Clinical Evaluation

Basic Level : CMDA – Certified Medical Device Associate
Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
IRB Review of Medical Devices 148153 mins€ 497.00€ 373.00
ISO 14155:2020 – A Summary Review 14480 mins€ 260.00€ 195.00
ISO 14155 VERSION 2011 VS 2020 GAP ANALYSIS 1760 mins€ 330.00€ 116.00
Medical Device GCP: A Practical Summary N19175 mins€ 243.00€ 183.00
Safety Reporting Requirements 2 course Suite
US Safety Reporting Requirements during Pre-Market Clinical Trials 9020 mins€ 65.00€ 48.00
European Safety Reporting Requirements during Clinical Investigations New!!8225 mins€ 74.00€ 55.00
Medical Device GCP for Investigators
GCP for Investigators: Introduction to Medical Devices 19352 mins€ 114.00€ 86.00
GCP for Investigators: How to Qualify for Medical Device Clinical Investigations 20032 mins€ 95.00€ 72.00
GCP for Investigators: Ethics and Legal Processes for Medical Device Clinical Investigations 21225 mins€ 84.00€ 63.00
GCP for Investigators: Initiation of a Medical Device Clinical Investigation 20230 mins€ 95.00€ 72.00
GCP for Investigators: Clinical Investigation Conduct and Reporting 20451 mins€ 128.00€ 96.00
GCP for Investigators: Clinical Investigation Close out or Termination 20623 mins€ 66.00€ 50.00
Effective Monitoring of Medical Device Clinical Investigations
History of Good Clinical Practice (GCP) 4115 minsFREEFREE
Introduction to Good Clinical Practice 4245 mins€ 99.00€ 75.00
Introduction to Medical Device and Clinical Investigation Planning 4345 mins€ 146.00€ 110.00
The Clinical Investigation Plan 4445 mins€ 146.00€ 110.00
The Informed Consent Process 4545 mins€ 146.00€ 110.00
Ethics Committee(EC) / Institutional Review Board Requirements 4640 mins€ 130.00€ 98.00
Selecting Investigation Sites 4745 mins€ 146.00€ 110.00
Initiation Visit 4845 mins€ 146.00€ 110.00
Adverse Event Processes 5977 mins€ 218.00€ 163.00
The Periodic Monitoring Visit 56120 mins€ 389.00€ 293.00
Device Accountability 5020 mins€ 65.00€ 48.00
Deviations and Non-Compliance Handling 5115 mins€ 48.00€ 36.00
Source Document Verification 5230 mins€ 98.00€ 73.00
The Case Report Form Process 5345 mins€ 146.00€ 110.00
Visit Report Writing 5415 mins€ 48.00€ 36.00
The Close Down Visit 5530 mins€ 98.00€ 73.00
Overview of Data Management Plan and Query Process 10825 mins€ 81.00€ 61.00
Good Documentation Practices for Clinical Study Files 9645 mins€ 146.00€ 110.00
ISO 14155:2020 - GCP Certificate
ISO 14155:2020 - Scope N15840 mins€ 130.00€ 98.00
ISO 14155:2020 - Ethical Considerations N17530 mins€ 98.00€ 73.00
ISO 14155:2020 - Clinical Investigation Planning N17650 mins€ 163.00€ 122.00
ISO 14155:2020 - Clinical Investigation Conduct N17740 mins€ 130.00€ 98.00
ISO 14155:2020 - Clinical Investigation Close Out N17825 mins€ 81.00€ 61.00
ISO 14155:2020 - Responsibilities of Sponsor N18445 mins€ 146.00€ 110.00
ISO 14155:2020 - Responsibilities of Principal Investigator N18535 mins€ 113.00€ 86.00
ISO 14155:2020: 综述
ISO 14155_课程1_范围 N21340 mins€ 130.00€ 98.00
ISO 14155_课程2_伦理和知情同意 N21430 mins€ 98.00€ 73.00
ISO 14155_课程3_临床试验策划 N21550 mins€ 163.00€ 122.00
ISO 14155_课程4_临床试验的开展 N21640 mins€ 130.00€ 98.00
ISO 14155_课程5_临床试验关闭 N21725 mins€ 81.00€ 61.00
ISO 14155_课程6_申办方职责 N21845 mins€ 146.00€ 110.00
ISO 14155_课程7_主要研究者职责 N21935 mins€ 113.00€ 86.00
医疗器械GCP_研究者篇
课程1：医疗器械简介 N20552 mins€ 114.00€ 86.00
如何进行医疗器械临床试验相关资质评估 N20632 mins€ 95.00€ 72.00
医疗器械临床试验伦理和合法流程 N20925 mins€ 84.00€ 63.00
临床试验的启动 N20730 mins€ 95.00€ 72.00
临床试验开展与报告 N21051 mins€ 128.00€ 96.00
临床试验关闭或终止 N20823 mins€ 66.00€ 50.00

Clinical Evaluation

Advanced Level : CMDP – Certified Medical Device Professional
Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
Clinical Data for Reimbursement 15757 mins€ 256.00€ 193.00
Conducting studies using Electronic Data Capture 10930 mins€ 100.00€ 76.00
Applying GDPR to Medical Devices Clinical Investigations N24637 mins€ 124.00€ 94.00
EU-MDR 2017/745 Review for Clinical Professionals N24980 mins€ 234.00€ 176.00
ISO 14155 GCP for Medical Device Studies – Main Differences with ICH 6 N32545 mins€ 151.00€ 113.00
ISO 14155 – BPC pour les études de dispositifs médicaux : Principales différences avec ICH 6 N32645 mins€ 151.00€ 113.00
Auditing Medical Device Clinical Investigations
Clinical Audits: Fundamentals of Auditing Medical Device Clinical Investigations 21736 mins€ 121.00€ 90.00
Clinical Audits: Sponsor/Third Party Audits of Clinical Investigation sites 21866 mins€ 221.00€ 162.00
Clinical Audits: Auditing the Clinical Research Organisation and the Sponsor 21982 mins€ 275.00€ 206.00
Navigating International Medical Device Clinical Investigation Requirements
Conducting Medical Device Clinical Investigations in Germany N15785 mins€ 374.00€ 281.00
Safety Related Committee Establishment
Clinical Events Committee (CEC) Establishment 11490 mins€ 396.00€ 297.00
Data Safety & Monitoring Board (DSMB) Establishment 12790 mins€ 396.00€ 297.00
Clinical Evaluation for Market Approval
Clinical Evaluation for Market Approval 11680 mins€ 352.00€ 264.00

Regulatory Affairs

Basic Level : CMDA – Certified Medical Device Associate
Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
Complaint Handling and Reporting Process for Medical Devices 14165 mins€ 211.00€ 158.00
Demarcation of Medical Devices to Other Products 7560 mins€ 195.00€ 146.00
Pre-Market Approval for Medical Device in China N13953 mins€ 172.00€ 129.00
The European Medical Device New Regulation 2017/745 N180330 mins€ 925.00€ 694.00
The ASEAN Common Submission Dossier Template (CSDT) and Its Contents N20370 mins€ 220.00€ 165.00
Labeling Requirements for Medical Devices
Labeling Requirements for Medical Devices in Europe N13387 mins€ 283.00€ 212.00
Electronic Instructions for Use of Medical Devices in the European Union N14350 mins€ 167.00€ 125.00

Regulatory Affairs

Advanced Level : CMDP – Certified Medical Device Professional
Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
Understanding Clinical Evaluation for Notified Body and Regulatory Professionals
Clinical Evaluation Report: Review for Regulatory Professionals 10770 mins€ 308.00€ 231.00
Data from Prospective Clinical Investigation for CE-Mark: Review for Regulatory Professionals 12295 mins€ 418.00€ 314.00
Including an IVD on the Australian Register of Therapeutic Goods
IVD Australia: Basics for including an IVD on the ARTG N15044 mins€ 194.00€ 145.00
IVD Australia: The Use of GMDN Codes for IVDs in Australia N15145 mins€ 198.00€ 149.00
IVD Australia: Making Applications for Inclusion on the ARTG N15233 mins€ 145.00€ 109.00
IVD Australia: Obtaining a TGA Conformity Assessment Certificate for IVD devices N15340 mins€ 176.00€ 132.00
IVD Australia: Fees for Including an IVD Device on the TGA or ARTG N15443 mins€ 189.00€ 142.00

Quality Assurance

Basic Level : CMDA – Certified Medical Device Associate
Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
ISO 13485:2016 - Medical Devices Quality Management Systems Requirements for Regulatory Purposes 196183 mins€ 403.00€ 303.00
Overview of US FDA Quality System Regulation 11875 mins€ 330.00€ 248.00

Quality Assurance

Advanced Level : CMDP – Certified Medical Device Professional
Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
How to Navigate Through the ISO 13485 Certification Process 19544 mins€ 194.00€ 145.00
Preparing Successfully for a US FDA Medical Device Inspection 215109 mins€ 365.00€ 274.00
Internal Auditor Training for Medical Device Manufacturers 209214 mins€ 717.00€ 538.00
Project Management of Medical Device Development N13685 mins€ 374.00€ 281.00

Start-ups & Business Ethics

Basic Level : CMDA – Certified Medical Device Associate
Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
Introduction to Medical Devices from Idea to Market
The Lifecycle of Medical Devices from Idea to Market 15942 mins€ 136.00€ 102.00

General Interest

Advanced Level : CMDP – Certified Medical Device Professional
Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
Team Building 93100 mins€ 429.00€ 322.00
Effective Time Management N148176 mins€ 664.00€ 531.00

Certification Exams

Basic Level : CMDA – Certified Medical Device Associate
Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
CMDA Clinical Evaluation - Mock Exam N13190 mins€ 90.00€ 90.00