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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 Devices 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 
Standalone Software Under the Medical Devices Directives N13740 mins 
Imaging Modalities Used in Pre-Clinical Research N16162 mins€ 248.00€ 186.00
Validating Software used in Company Processes N16265 mins 
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 mins 
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
Performing a 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
The Hong Kong 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 
Singapore’s Regulatory System for Medical Devices 19168 mins€ 139.00€ 104.00
Pre-Market Approval for Medical Device in China N13953 mins 
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 Bringing Medical Devices 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 of 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 Pre-Market 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: Summary Technical Documentation (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
RoHS Directive 2011/65/EU & WEEE Directive 2012/19/EU N20033 mins€ 101.00€ 75.00
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 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

Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
ISO 13485 - Medical Devices Quality Management Systems Requirements for Regulatory Purposes 196183 mins€ 366.00€ 275.00
Importance of Technical Standards in the Medical Device Sector 18572 mins€ 213.00€ 159.00
Overview of US FDA Quality System Regulation 11875 mins 

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 
German Healthcare System 13535 mins 
French Healthcare System 13622 mins 
UK Healthcare System 13735 mins 
Italian Healthcare System 13820 mins 
Developing an EU Reimbursement Strategy for a Medical Device 13940 mins 

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 US 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 - Online Exam N13190 mins€ 80.00€ 80.00