Clinical Trials for Medical Devices
( 25 Modules )

Module #1
Introduction to Medical Device Clinical Trials
Overview of clinical trials for medical devices, importance, and regulatory framework

Module #2
History of Medical Device Regulation
Evolution of regulations and guidelines for medical device development and clinical trials

Module #3
Key Concepts in Clinical Trial Design
Understanding clinical trial design principles, types, and phases

Module #4
Regulatory Requirements for Medical Device Clinical Trials
FDA, EU MDR, and other regional regulatory requirements for clinical trials

Module #5
Device Classification and Risk Management
Understanding device classification, risk management, and impact on clinical trial design

Module #6
Clinical Trial Protocol Development
Creating a clinical trial protocol, including objectives, endpoints, and inclusion/exclusion criteria

Module #7
Investigational Device Exemption (IDE) Submission
Preparing and submitting an IDE application to the FDA

Module #8
Ethics in Medical Device Clinical Trials
Ethical principles, informed consent, and IRB review

Module #9
Clinical Trial Site Selection and Management
Identifying and managing clinical trial sites, including site feasibility and initiation

Module #10
Investigator Oversight and Training
Training and managing investigative site staff, including principal investigators and study coordinators

Module #11
Data Management and Statistical Analysis
Data collection, management, and statistical analysis for medical device clinical trials

Module #12
Monitoring and Quality Control
On-site monitoring, data quality control, and risk-based monitoring strategies

Module #13
Adverse Event Reporting and Safety Management
Identifying, reporting, and managing adverse events during clinical trials

Module #14
Data Safety Monitoring Board (DSMB) and Independent Ethics Committee (IEC)
Roles and responsibilities of DSMB and IEC in ensuring participant safety

Module #15
Covid-19 and Remote Clinical Trials
Conducting clinical trials during the pandemic, including remote monitoring and virtual trials

Module #16
Post-Market Surveillance and Vigilance
Post-approval responsibilities, including post-market surveillance and vigilance reporting

Module #17
Regulatory Inspections and Audits
Preparing for and responding to regulatory inspections and audits

Module #18
Clinical Trial Results and Publication
Publishing clinical trial results, including manuscript preparation and submission

Module #19
Medical Device Labeling and Instructions for Use
Developing and managing medical device labeling and instructions for use

Module #20
Global Harmonization and Regulatory Considerations
Regulatory considerations for conducting clinical trials globally, including ICH and other international guidelines

Module #21
Risk Management and Quality Systems
Implementing quality systems and risk management principles in medical device development and clinical trials

Module #22
Medical Device Software and Cybersecurity
Regulatory considerations for medical device software and cybersecurity in clinical trials

Module #23
Real-World Evidence and Post-Market Studies
Leveraging real-world evidence and conducting post-market studies to support medical device development

Module #24
Patient Engagement and Advocacy in Clinical Trials
Involving patients in clinical trial design and execution, including patient advocacy and engagement strategies

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Clinical Trials for Medical Devices career

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Clinical Trials for Medical Devices ( 25 Modules )

Clinical Trials for Medical Devices
( 25 Modules )