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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 
ISO 14155:2020 – A Summary Review 14480 mins€ 260.00€ 195.00
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 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 
Good Documentation Practices for Clinical Study Files 9645 mins 
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 
Centralized vs. Onsite Monitoring Applying FDA’s Risk-Based Approach N19050 mins 
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 – Main Differences with ICH 6 clinical professionals should know N32545 mins€ 151.00€ 113.00
EU Clinical Investigation Agreements
Understanding EU Clinical Investigation Agreements 11140 mins 
Negotiating EU Clinical Investigation Agreements 11240 mins 
Navigating International Medical Device Clinical Investigation Requirements
Conducting Medical Device Clinical Investigations in Switzerland N13835 mins 
Medical Device Clinical Investigation in Germany – Requirements of the Radiation Ordinances N15950 mins 
Safety Related Committee Establishment
Clinical Events Committee (CEC) Establishment 11490 mins 
Data Safety & Monitoring Board (DSMB) Establishment 12790 mins 
Clinical Evaluation for Market Approval
Clinical Evaluation for Market Approval New!!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
Role of RA Specialist in the Design Process 15440 mins 
Pre-Market Approval for Medical Device in China N13953 mins 
The European Medical Device New Regulation 2017/745 N180330 mins€ 925.00€ 694.00
Current and upcoming IVD market access requirements in Europe
The Draft European IVD Regulation N18150 mins 

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

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 

Quality Assurance

Advanced Level : CMDP – Certified Medical Device Professional
Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
Preparing Successfully for a US FDA Medical Device Inspection 215109 mins 

General Interest

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

General Interest

Advanced Level : CMDP – Certified Medical Device Professional
Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
Effective Time Management N148176 mins 

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