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€ 186.00€ 144.00
Introduction to Process Validation N13575 mins€ 221.00€ 166.00
Validation of Ethylene Oxide Sterilization of Medical Devices N18653 mins€ 156.00€ 117.00

Pre-Clinical

Advanced Level : CMDP – Certified Medical Device Professional
Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
Understanding Software Validation 22754 mins€ 216.00€ 162.00
Biocompatibility of Medical Devices N18850 mins€ 151.00€ 113.00
IEC 60601-1 Ed 3.1 Compliance Program
IEC 60601-1 Ed 3.1 - Background and Introduction N11445 mins€ 176.00€ 132.00
IEC 60601-1 Ed 3.1 - Risk Management and General Requirements N19659 mins€ 236.00€ 177.00
IEC 60601-1 Ed 3.1 - Protection Against Electrical Shock, and verifying Electrical Insulation N19794 mins€ 376.00€ 282.00
IEC 60601-1 Ed 3.1 - Medical Electrical Systems and Protection Against Mechanical Hazards N19869 mins€ 276.00€ 207.00
IEC 60601-1 Ed 3.1 - Protection Against Thermal and Other Hazards and Components N19954 mins€ 216.00€ 162.00

Clinical Evaluation

Basic Level : CMDA – Certified Medical Device Associate
Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
Importance of Clinical Investigator´s Brochure (IB) 11785 mins€ 332.00€ 249.00
IRB Review of Medical Devices 148153 mins€ 452.00€ 339.00
ISO 14155:2020 – A Summary Review 14480 mins€ 236.00€ 177.00
ISO 14155 VERSION 2011 VS 2020 GAP ANALYSIS 1760 mins€ 300.00€ 105.00
Managing Data Release Consent During Post Market Studies 22631 mins€ 58.00€ 44.00
Safety Reporting Requirements 2 course Suite
US Safety Reporting Requirements during Pre-Market Clinical Trials 9020 mins€ 59.00€ 44.00
European Safety Reporting Requirements during Pre-Market clinical Investigations 8225 mins€ 74.00€ 55.00
Medical Device GCP for Investigators
GCP for Investigators: Introduction to Medical Devices 19352 mins€ 104.00€ 78.00
GCP for Investigators: How to Qualify for Medical Device Clinical Investigations 20032 mins€ 86.00€ 65.00
GCP for Investigators: Ethics and Legal Processes for Medical Device Clinical Investigations 21225 mins€ 76.00€ 57.00
GCP for Investigators: Initiation of a Medical Device Clinical Investigation 20230 mins€ 86.00€ 65.00
GCP for Investigators: Clinical Investigation Conduct and Reporting 20451 mins€ 116.00€ 87.00
GCP for Investigators: Clinical Investigation Close out or Termination 20623 mins€ 60.00€ 45.00
Effective Monitoring of Medical Device Clinical Investigations
History of Good Clinical Practice (GCP) 4115 minsFREEFREE
Introduction to Good Clinical Practice 4245 mins€ 90.00€ 68.00
Introduction to Medical Device and Clinical Investigation Planning 4345 mins€ 133.00€ 100.00
The Clinical Investigation Plan 4445 mins€ 133.00€ 100.00
The Informed Consent Process 4545 mins€ 133.00€ 100.00
Ethics Committee(EC) / Institutional Review Board Requirements 4640 mins€ 118.00€ 89.00
Selecting Investigation Sites 4745 mins€ 133.00€ 100.00
Initiation Visit 4845 mins€ 133.00€ 100.00
Adverse Event Processes 5977 mins€ 198.00€ 148.00
The Periodic Monitoring Visit 56120 mins€ 354.00€ 266.00
Device Accountability 5020 mins€ 59.00€ 44.00
Deviations and Non-Compliance Handling 5115 mins€ 44.00€ 33.00
Source Document Verification 5230 mins€ 89.00€ 66.00
The Case Report Form Process 5345 mins€ 133.00€ 100.00
Visit Report Writing 5415 mins€ 44.00€ 33.00
The Close Down Visit 5530 mins€ 89.00€ 66.00
Overview of Data Management Plan and Query Process 10825 mins€ 74.00€ 55.00
Good Documentation Practices for Clinical Study Files 9645 mins€ 133.00€ 100.00
ISO 14155:2020 - GCP Certificate
ISO 14155:2020 - Scope N15840 mins€ 118.00€ 89.00
ISO 14155:2020 - Ethical Considerations N17530 mins€ 89.00€ 66.00
ISO 14155:2020 - Clinical Investigation Planning N17650 mins€ 148.00€ 111.00
ISO 14155:2020 - Clinical Investigation Conduct N17740 mins€ 118.00€ 89.00
ISO 14155:2020 - Clinical Investigation Close Out N17825 mins€ 74.00€ 55.00
ISO 14155:2020 - Responsibilities of Sponsor N18445 mins€ 133.00€ 100.00
ISO 14155:2020 - Responsibilities of Principal Investigator N18535 mins€ 103.00€ 78.00
ISO 14155:2020: 综述
ISO 14155_课程1_范围 N21340 mins€ 118.00€ 89.00
ISO 14155_课程2_伦理和知情同意 N21430 mins€ 89.00€ 66.00
ISO 14155_课程3_临床试验策划 N21550 mins€ 148.00€ 111.00
ISO 14155_课程4_临床试验的开展 N21640 mins€ 118.00€ 89.00
ISO 14155_课程5_临床试验关闭 N21725 mins€ 74.00€ 55.00
ISO 14155_课程6_申办方职责 N21845 mins€ 133.00€ 100.00
ISO 14155_课程7_主要研究者职责 N21935 mins€ 103.00€ 78.00
医疗器械GCP_研究者篇
课程1：医疗器械简介 N20552 mins€ 104.00€ 78.00
如何进行医疗器械临床试验相关资质评估 N20632 mins€ 86.00€ 65.00
医疗器械临床试验伦理和合法流程 N20925 mins€ 76.00€ 57.00
临床试验的启动 N20730 mins€ 86.00€ 65.00
临床试验开展与报告 N21051 mins€ 116.00€ 87.00
临床试验关闭或终止 N20823 mins€ 60.00€ 45.00

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€ 233.00€ 175.00
Conducting studies using Electronic Data Capture 10930 mins€ 91.00€ 69.00
Centralized vs. Onsite Monitoring Applying FDA’s Risk-Based Approach N19050 mins€ 152.00€ 114.00
Applying GDPR to Medical Devices Clinical Investigations N24637 mins€ 113.00€ 85.00
EU-MDR 2017/745 Review for Clinical Professionals N24980 mins€ 213.00€ 160.00
Auditing Medical Device Clinical Investigations
Clinical Audits: Fundamentals of Auditing Medical Device Clinical Investigations 21736 mins€ 110.00€ 82.00
Clinical Audits: Sponsor/Third Party Audits of Clinical Investigation sites 21866 mins€ 201.00€ 151.00
Clinical Audits: Auditing the Clinical Research Organisation and the Sponsor 21982 mins€ 250.00€ 187.00
Navigating International Medical Device Clinical Investigation Requirements
Conducting Medical Device Clinical Investigations in Switzerland N13835 mins€ 107.00€ 80.00
Conducting Medical Device Clinical Investigations in Germany N15785 mins€ 340.00€ 255.00
Safety Related Committee Establishment
Clinical Events Committee (CEC) Establishment 11490 mins€ 360.00€ 270.00
Data Safety & Monitoring Board (DSMB) Establishment 12790 mins€ 360.00€ 270.00
Clinical Project Management Complete 10 course Suite
CPM: Objectives and Setup of a Medical Device Clinical Trial 9735 mins€ 160.00€ 120.00
CPM: The Clinical Trial master plan for Medical Devices 9850 mins€ 200.00€ 150.00
CPM: Medical Device Clinical Trials - Budget and Timelines Planning 99100 mins€ 400.00€ 300.00
CPM: Medical Device Clinical Trial Team Resources 10050 mins€ 200.00€ 150.00
CPM: Tracking and Reporting Rules for Medical Device Clinical Trials 10125 mins€ 100.00€ 75.00
CPM: Project Guidelines for Medical Device Clinical Trials 10230 mins€ 120.00€ 90.00
CPM: Managing Ongoing Medical Device Clinical Trials 10320 mins€ 80.00€ 60.00
CPM: Compliance Management during Medical Device Clinical Trials 10440 mins€ 160.00€ 120.00
CPM: Effective Communication Methods during Medical Device Clinical Trials 10550 mins€ 200.00€ 150.00
CPM: Close Out and Clinical Report of a Medical Device Clinical Trial 10630 mins€ 120.00€ 90.00
Clinical Evaluation for Market Approval
Clinical Evaluation for Market Approval 11680 mins€ 320.00€ 240.00
Designing a Strategic Clinical Investigation Plan
Format and Structure of a Medical Device Clinical Investigation Plan/Protocol N14042 mins€ 132.00€ 99.00
Designing a Strategic Medical Device Clinical Investigation Plan/Protocol N14190 mins€ 454.00€ 341.00
Clinical Protocol Writing Process and Ensuring Compliance N14235 mins€ 110.00€ 83.00

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€ 192.00€ 144.00
Demarcation of Medical Devices to Other Products 7560 mins€ 177.00€ 133.00
Pre-Market Approval for Medical Device in China N13953 mins€ 156.00€ 117.00
The European Medical Device New Regulation 2017/745 N180330 mins€ 841.00€ 631.00
The ASEAN Common Submission Dossier Template (CSDT) and Its Contents N20370 mins€ 200.00€ 150.00
Labeling Requirements for Medical Devices
Labeling Requirements for Medical Devices in Europe N13387 mins€ 257.00€ 193.00
Electronic Instructions for Use of Medical Devices in the European Union N14350 mins€ 152.00€ 114.00

Regulatory Affairs

Advanced Level : CMDP – Certified Medical Device Professional
Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
Risk Management for Medical Devices in the EU and US
ISO 14971: 2007 Review 7835 mins€ 107.00€ 80.00
Preparing Risk Management File & Which Techniques Apply 8324 mins€ 73.00€ 55.00
Integrating Risk Management into Your Quality Management System 9435 mins€ 107.00€ 80.00
Implications of EN ISO 14971:2012 N18928 mins€ 85.00€ 64.00
Understanding Clinical Evaluation for Notified Body and Regulatory Professionals
Clinical Evaluation Report: Review for Regulatory Professionals 10770 mins€ 280.00€ 210.00
Data from Prospective Clinical Investigation for CE-Mark: Review for Regulatory Professionals 12295 mins€ 380.00€ 285.00
Including an IVD on the Australian Register of Therapeutic Goods
IVD Australia: Basics for including an IVD on the ARTG N15044 mins€ 176.00€ 132.00
IVD Australia: The Use of GMDN Codes for IVDs in Australia N15145 mins€ 180.00€ 135.00
IVD Australia: Making Applications for Inclusion on the ARTG N15233 mins€ 132.00€ 99.00
IVD Australia: Obtaining a TGA Conformity Assessment Certificate for IVD devices N15340 mins€ 160.00€ 120.00
IVD Australia: Fees for Including an IVD Device on the TGA or ARTG N15443 mins€ 172.00€ 129.00

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€ 366.00€ 275.00
Overview of US FDA Quality System Regulation 11875 mins€ 300.00€ 225.00

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€ 176.00€ 132.00
Preparing Successfully for a US FDA Medical Device Inspection 215109 mins€ 332.00€ 249.00
Internal Auditor Training for Medical Device Manufacturers 209214 mins€ 652.00€ 489.00
Project Management of Medical Device Development N13685 mins€ 340.00€ 255.00

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€ 124.00€ 93.00

General Interest

Basic Level : CMDA – Certified Medical Device Associate
Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
Powerful Presentation Skills 70140 mins€ 267.00€ 200.00

General Interest

Advanced Level : CMDP – Certified Medical Device Professional
Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
Team Building 93100 mins€ 390.00€ 293.00
Effective Time Management N148176 mins€ 604.00€ 483.00

Certification Exams

Basic Level : CMDA – Certified Medical Device Associate
Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
CMDA Clinical Evaluation - Online Exam N13190 mins€ 80.00€ 80.00