Introduction to Clinical Research with Medical Devices – eLearning
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| Date | Product | Location | Price | |
|---|---|---|---|---|
| Introduction to Clinical Research with Medical Devices | eLearning | EUR 450 | Book | |
| If you would like to have this course as an in-house session click here | ||||
About this course
Reasons to attend
Do you know how medical devices find their way to the market? Are you aware that medical applications on a mobile phone and digital medical wearables must be systematically tested before they can be used for medical purposes? Do you know differences between clinical investigations with medical devices and clinical trials with drugs? If your answer is no, then this course is a good way to get familiar with rules, principles and terms and definitions typically used in the fast-growing industry of medical device development.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been certified by TransCelerate BioPharma
- This course has been reviewed by the Belgian GCP Inspectorate.
Course schedule
- Course credit: 3h (3 months period to complete course)
- Complete the course at anytime, anywhere!
Course Description
Are clinical investigations with medical devices is new to you? This interactive course outlines the current regulatory framework and concepts of medical device development. It explains definitions and the classification principles of different types of medical devices and touches on the main differences with pharmaceutical products.Regarding testing of medical devices, the principles of good clinical practice as well as different steps during clinical investigations are depicted from start to finish. You will be introduced to the basic elements of the mandatory risk-based approach and to the cycles of clinical evaluation, both crucial to get products on the market.This online introductory course also serves as a basis for all other ECCRT courses on medical device development. Matching drag and drop exercises and interactive quizzes are included in this online course that will give you immediate feedback on your comprehension, helping you to maximise your learning journey.You will be able to test your understanding with a final graded test. Supporting information, updates and your course certificate can be found on our Virtual Campus.Programme highlight
- Development pathway and regulatory framework
- Definitions and classification of medical devices
- Differences between medical devices and medicinal product development
- Legislation and standards governing clinical trials with devices
- Clinical investigation requirements according to study types
- Fundamentals of Good Clinical Practice for all the stakeholders
- Elements of the clinical trial cycle from start to finish
- Concepts of risk-based management and clinical evaluation
Learning objectives
- Define steps to get a medical device to the market
- Pick up basics of the legislative rules in medical device development
- Differentiate between various classes of medical devices
- Recognize differences between drug and device development
- Describe the cycle of a clinical investigation from start to finish
Who should attend
Everyone involved in clinical research who recently entered or will enter the medical device field. Previous experience in clinical research is not required.
Competencies
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