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!
MDR Fundamentals
$79.00
- Course Type: Video Lessons
- Language: English
- Level: Intermediate
- Session: year 2020
- Time: 1 - 3 Hours
Course Breakdown
| Section | Time |
|---|---|
| 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 |
Exam and Certifications
- Final test for MDR Roadmap (EU 101-A)
- Final test for Clinical Evaluation 2020 (EU 110)
- Certification
Description
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.
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