- Introduction
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Course goals
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Welcome
- Clinical research of medical devices
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Introduction to clinical research of medical devices
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Quiz - Introduction to clinical research of medical devices
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What is a medical device?
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Quiz - What is a medical device?
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Clinical research of drugs vs devices
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Quiz - Clinical research of drugs vs devices
- Clinical practice and ISO 14155
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What is good clinical practice (GCP)?
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Quiz - What is good clinical practice (GCP)?
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Who must follow GCP?
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Quiz - Who must follow GCP?
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ISO 14155 content, clauses, and annexes
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Quiz - ISO 14155 content, clauses, and annexes
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Major changes in the new version ISO 14155:2020
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Quiz - Major changes in the new version ISO 14155:2020
- How to study and market a medical device
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Development of medical devices
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Quiz - Development of medical devices
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Regulatory requirements EU MDR 2017/745 – Part 1
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Regulatory requirements EU MDR 2017/745 – Part 2
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Quiz - Regulatory requirements EU MDR 2017/745
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Clinical investigations and risk management
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Quiz - Clinical investigations and risk management
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Risk and clinical investigation stages
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Quiz - Risk and clinical investigation stages
- Clinical study planning
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Clinical investigation milestones
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Quiz - Clinical investigation milestones
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Identifying stakeholders
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Quiz - Identifying stakeholders
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Developing essential documents – Part 1
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Developing essential documents – Part 2
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Quiz - Developing essential documents
- Clinical study start up
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Site selection – qualification of sites and investigators
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Quiz - Site selection – qualification of sites and investigators
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EC and CA submissions and agreements – Part 1
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EC and CA submissions and agreements – Part 2
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Quiz - EC and CA submissions and agreements
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Site initiation
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Quiz - Site initiation
- Clinical study conduct
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Site Management – Devices, documents, and training
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Quiz - Site Management – Devices, documents, and training
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Safety reporting
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Quiz - Safety reporting
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Site monitoring
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Quiz - Site monitoring
- Clinical study termination
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End of enrolment
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Quiz - End of enrolment
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Site close-out
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Quiz - Site close-out
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Clinical investigation report
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Quiz - Clinical investigation report
- Summary of responsibilities for clinical investigations
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Summary of sponsor responsibilities
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Quiz - Summary of sponsor responsibilities
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Summary of investigator responsibilities
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Quiz - Summary of investigator responsibilities
- Financing and managing a clinical investigation
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Preparing a clinical investigation budget
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Quiz - Preparing a clinical investigation budget
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Setting up a successful clinical investigation - Part 1
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Setting up a successful clinical investigation - Part 2
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Quiz - Setting up a successful clinical investigation
- Final exam
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Final exam - Clinical investigation
- Course evaluation
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Course evaluation
Introduction to Clinical Investigation for Medical Devices and ISO 14155
Learn how to optimise the planning and conduct of clinical investigations for medical devices during this self-paced, interactive online course.
This online course focuses on good clinical practice (GCP) for the design, conduct, recording, and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.
The course covers an orientation of the clinical investigation process according to the EN ISO 14155:2020 standard and the standard’s relation to MDCG guidance documents.
Learners will have access to the online course for 6 months to review the material and pass the exam. One exam attempt is included and the score earned will be printed on the learner's certificate.
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