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Pre-Clinical

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 Device N18653 mins€ 156.00€ 117.00

Pre-Clinical

Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
Good Laboratory Practices & Biological Evaluation for Medical Devices 11070 mins€ 213.00€ 160.00
Understanding Software Validation 22754 mins€ 216.00€ 162.00
Standalone Software Under the Medical Devices Directives N13740 mins€ 160.00€ 120.00
Imaging Modalities Used in Preclinical Research N16162 mins€ 248.00€ 186.00
Validating Software used in Company Processes N16265 mins€ 260.00€ 195.00
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

Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
Accelerating Successful Patient Recruitment 11970 mins€ 207.00€ 155.00
Directive 93/42/EEC and update 2007/47/EC: A review for clinical professionals (rev 1.2) 6060 mins€ 183.00€ 137.00
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 Version 2003 vs. 2011: Gap Analysis 1760 mins€ 300.00€ 105.00
Managing Data Release Consent During Post Market Studies 22631 mins€ 58.00€ 44.00
The European Medical Device New Regulation N18038 minsFREEFREE
Medical Device GCP: A Practical Summary N19175 mins€ 221.00€ 166.00
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
ISO 14155: In Depth Review
ISO 14155:2011- Scope 6120 mins€ 61.00€ 46.00
ISO 14155:2011 - Ethical Considerations 6220 mins€ 61.00€ 46.00
ISO 14155:2011 - Clinical Investigation Planning 6330 mins€ 61.00€ 46.00
ISO 14155:2011 - Clinical Investigation Conduct 6440 mins€ 122.00€ 91.00
ISO 14155:2011 - Clinical Investigation Close Out 6520 mins€ 61.00€ 46.00
ISO 14155:2011 - Responsibilities of Sponsor 6645 mins€ 137.00€ 103.00
ISO 14155:2011 - Responsibilities of Principal Investigator 6730 mins€ 91.00€ 69.00
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

Clinical Evaluation

Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
Conducting studies using Electronic Data Capture 10930 mins€ 91.00€ 69.00
ISO 14155: 2011 – A Summary Review 14444 mins€ 134.00€ 100.00
Centralized vs. Onsite Monitoring Applying FDA’s Risk-Based Approach N19050 mins€ 152.00€ 114.00
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
US Bioresearch Monitoring 3 Course Suite
BIMO: US FDA BIMO Compliance Program 14354 mins€ 165.00€ 123.00
BIMO: IDE Sponsor Obligations 150180 mins€ 549.00€ 411.00
BIMO: IDE Investigator Obligations 155190 mins€ 594.00€ 446.00
EU Clinical Investigation Agreements
Understanding EU Clinical Investigation Agreements 11140 mins€ 122.00€ 91.00
Negotiating EU Clinical Investigation Agreements 11240 mins€ 122.00€ 91.00
Navigating International Medical Device Clinical Investigation Requirements
Conducting Medical Device Clinical Investigations in Switzerland N13834 mins€ 104.00€ 78.00
Conducting Medical Device Clinical Investigations in Germany N15785 mins€ 340.00€ 255.00
Medical Device Clinical Investigation in Germany – Requirements of the Radiation Ordinances N15950 mins€ 200.00€ 150.00
Conducting Medical Device Clinical Investigations in Romania N16520 mins€ 61.00€ 46.00
Conducting Medical Device Clinical Investigations in Singapore N16425 mins€ 76.00€ 57.00
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 Data for Reimbursement 15757 mins€ 233.00€ 175.00
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 EU Market Approval: Process and Regulatory background 11680 mins€ 328.00€ 246.00
Clinical Evaluation for EU Market Approval: Literature Review 12050 mins€ 205.00€ 154.00
Clinical Evaluation for EU Market Approval: Step by Step Primer 12458 mins€ 238.00€ 178.00
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

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
Role of RA Specialist in the Design Process 15440 mins€ 118.00€ 89.00
The Australian Regulatory System for In-Vitro Diagnostic (IVD) Devices 13280 mins€ 390.00€ 293.00
Regulatory Framework for In Vitro Medical Devices in the US N14960 mins€ 177.00€ 133.00
Navigating International Regulatory Systems
Introduction to the US FDA 7625 minsFREEFREE
Hong Kong´s Regulatory System for Medical Devices 18672 mins€ 213.00€ 159.00
The Australian Regulatory System for Medical Devices 113110 mins€ 325.00€ 244.00
The European Union Regulatory System for Medical Devices 145175 mins€ 517.00€ 388.00
The Japanese Regulatory System for Medical Devices 14695 mins€ 280.00€ 210.00
The Singapore Regulatory System for Medical Devices 19151 mins€ 139.00€ 104.00
Pre-Market Approval for Medical Device in China N13953 mins€ 156.00€ 117.00
Medical Device Pre-Market Approval Process in Korea N15560 mins€ 177.00€ 133.00
Registration Process for Medical Devices in Brazil N17453 mins€ 156.00€ 117.00
Strategic Approach to Bring a Medical Device to the Indonesian Market N14650 mins€ 148.00€ 111.00
Labeling Requirements for Medical Devices
Labeling Requirements for Medical Devices in Europe N13387 mins€ 257.00€ 193.00
Electronic Instructions for Use for Medical Devices in the European Union N14350 mins€ 152.00€ 114.00
Labeling Requirements for Medical Devices in the US N14470 mins€ 207.00€ 155.00
GHTF/IMDRF Regulatory Model for Medical Devices
Introduction to the GHTF or IMDRF N16925 mins€ 74.00€ 55.00
GHTF/IMDRF – The Premarket Model N17030 mins€ 89.00€ 66.00
GHTF/IMDRF – The Post-Market Model N17130 mins€ 89.00€ 66.00
GHTF/IMDRF – Supporting Documents N17230 mins€ 89.00€ 66.00
GHTF/IMDRF – International Implementation N17335 mins€ 103.00€ 78.00
GHTF/IMDRF – Essential Principles of Safety and Performance for Medical Devices N18283 mins€ 245.00€ 184.00
GHTF/IMDRF – The STED and Its Contents N18750 mins€ 148.00€ 111.00
Current and upcoming IVD market access requirements in Europe
Pathways to CE Marking under the In Vitro Diagnostics Directive N16850 mins€ 148.00€ 111.00
The Draft European IVD Regulation N18150 mins€ 152.00€ 114.00

Regulatory Affairs

Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
Good Documentation & Writing Practices for Regulatory Submissions 12960 mins€ 234.00€ 176.00
US FDA 510(k) Notification Process 9250 mins€ 152.00€ 114.00
US FDA Investigational Device Exemption (IDE) Overview 121125 mins€ 381.00€ 286.00
Active Medical Devices in Europe: Particular Requirements N18358 mins€ 177.00€ 133.00
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 of Existing data for CE-mark: review for regulatory professionals 10750 mins€ 200.00€ 150.00
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 application 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 ARTG N15443 mins€ 172.00€ 129.00

Quality Assurance

Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
ISO 13485: Foundation and Basic Principles 196152 mins€ 304.00€ 228.00
Importance of Technical Standards in the Medical Device Sector 18572 mins€ 213.00€ 159.00
Overview of US FDA Quality System Regulation 11875 mins€ 300.00€ 225.00

Quality Assurance

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

Health Economics & Reimbursement

Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
The Basics of US Private Payer Reimbursement for Medical Devices 14032 mins€ 64.00€ 48.00
Reimbursement Strategy for Medical Devices in the US 15645 mins€ 86.00€ 64.00
Introduction to EU Funding and Reimbursement of Medical Devices
Introduction to European Funding and Reimbursement Systems 13440 mins€ 118.00€ 89.00
German Healthcare System 13535 mins€ 103.00€ 78.00
French Healthcare System 13622 mins€ 88.00€ 49.00
UK Healthcare System 13735 mins€ 103.00€ 78.00
Italian Healthcare System 13820 mins€ 59.00€ 44.00
Developing an EU Reimbursement Strategy for a Medical Device 13940 mins€ 118.00€ 89.00

Health Economics & Reimbursement

Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
Health Economic Evaluation of Medical Technologies 11565 mins€ 322.00€ 241.00

Combination Products

Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
Introduction to Combination Products in the USA 21362 mins€ 242.00€ 182.00
Introduction to Drug-Device Combination Regulations in Europe N16055 mins€ 162.00€ 122.00

Start-ups & Business Ethics

Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
Introduction to Digital Governance: A Four-Step Approach 18457 mins€ 168.00€ 126.00
Introduction to Medical Devices from Idea to Market
The Lifecycle of Medical Devices from Idea to Market 15942 mins€ 124.00€ 93.00
Creating Value in Healthcare 17544 mins€ 172.00€ 129.00
Introduction to the EU Regulatory System 16036 mins€ 106.00€ 80.00
What is considered a Medical Device? 16140 mins€ 118.00€ 89.00
Steps to CE Mark 16252 mins€ 154.00€ 115.00
The Main Concepts for Safe and Performing Devices 16339 mins€ 115.00€ 86.00
Clinical Evaluation of Medical Devices: an Introduction 16543 mins€ 127.00€ 95.00
Post Market Surveillance: an Introduction 16634 mins€ 100.00€ 75.00

Start-ups & Business Ethics

Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
Developing Markets for Medical Technologies: How to Drive Adoption 22042 mins€ 168.00€ 126.00
Introduction to Medical Devices from Idea to Market
Intellectual Property Concepts for Medical Devices N13238 mins€ 112.00€ 84.00
Business Plan Essentials for Medical Products 17760 mins€ 246.00€ 184.00

General Interest

Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
Powerful Presentation Skills 70140 mins€ 267.00€ 200.00

General Interest

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
Applied Project Management
Applied Project Management: Project! 7223 mins€ 68.00€ 51.00
Applied Project Management: Project Stakeholders 7320 mins€ 59.00€ 44.00
Applied Project Management: Objectives and Arena 7430 mins€ 89.00€ 66.00
Applied Project Management: Visualizing 8410 mins€ 30.00€ 22.00
Applied Project Management: Project Planning 8540 mins€ 118.00€ 89.00
Applied Project Management: Project Organization 8635 mins€ 103.00€ 78.00
Applied Project Management: Project Environment 8730 mins€ 89.00€ 66.00
Applied Project Management: Risks and Opportunities 8830 mins€ 89.00€ 66.00
Applied Project Management: Project Realization 8960 mins€ 177.00€ 133.00
Applied Project Management: Project Leadership 9150 mins€ 148.00€ 111.00

Certification Exams

Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
CMDA Clinical Evaluation - Test Exam online N13190 mins€ 80.00€ 80.00