- MDR Roadmap and Orientation Program (00:58:00)
- Clinical Evaluation 2020 (00:39:00)
- New ISO 14155:2020 Key Changes for Your Trial (00:15:00)
Welcome to the Meditrial MDR Fundamentals. In three easy VIDEO-COURSES, you will learn all the essential information regarding the MDR changes and the new procedures for Clinical Evaluation and clinical trials, including a learning module on the new standard 14155. Get ready to learn all you need to know on the new European regulation for medical devices. After the courses, you can take a brief test to receive your certification. Enjoy!
Why take this course
There are significant changes that affect all companies that produce medical devices and wish to sell them in Europe. The new medical device regulation has introduced some new aspects and more complex rules will impact manufacturers, operators, health professionals and the public.
What I will learn
- MDR Structure and Key changes to the Regulation
- MDR Scope and Definitions
- Responsibilities and obligations of Economic Operators
- EUDAMED and UDI
- Device classification and Conformity assessment
- Clinical evaluation and investigations
- Surveillance and Vigilance
Skills I will gain
- Understand the principles, framework and procedures described in MDR
- Learn the scope and definitions followed by economic operators
- Learn how MDR regulates the manufacturing and marketing of medical devices in the EU
- Understand clinical evaluation and investigations along with surveillance and vigilance of medical devices.
- Final test for MDR Roadmap (EU 101-A)
- Final test for Clinical Evaluation 2020 (EU 110)
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