This course presents an overview of the new European regulation for medical devices and provides key information regarding new changes within the MDR. Learn all you need to know for a successful transition to the new legislative framework.
Introduction to Medical Device Regulation Roadmap & Orientation
$49.00
- Course Type: Video Lessons
- Language: English
- Level: Beginner
- Session: year 2020
- Time: 0 - 1 Hour
Course Breakdown
| Section | Time |
|---|---|
| Introduction | 00:01:23 |
| Classification of Medical Devices | 00:01:50 |
| MDR Definitions for Clinical Investigation | 00:02:21 |
| Types of Investigations | 00:06:24 |
| Clinical Evaluation and Investigation | 00:02:12 |
| Vigilance and Safety Reporting | 00:02:47 |
| Timelines and Grace Period | 00:05:12 |
| Conclusion | 00:03:36 |
Exam and Certifications
- Final Test – Introduction to Medical Device Regulation Roadmap & Orientation
- Certification
Description
What I will learn?
- Fundamental Concepts regarding the new MDR
- MDR Scope and Definitions
- Key changes to clinical trials
- Responsibilities and obligations of Economic Operators
- 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 how MDR regulates the manufacturing and marketing of medical devices in the EU
- Set a strategy to meet the new requirements and get your product to the market
- Understand your responsibilities and obligations as a manufacturer, EU representatives, importers and distributors of medical devices Class I to III
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