This lecture presents the roadmap of the new European regulation for medical devices and provides an orientation to navigate all the key changes. Learn all you need to know for a successful transition to the new legislative framework.
Medical Device Regulation Roadmap And Orientation
$79.00
- Course Type: Video Lecture
- Language: English
- Level: Advanced
- Session: year 2020
- Time: 1 - 3 Hours
Course Breakdown
| Section | Time |
|---|---|
| Introduction | 00:01:48 |
| Meditrial Expert Speaker and Tools | 00:01:33 |
| Key Changes in MDR | 00:05:05 |
| MDR Structure | 00:05:53 |
| MDR Scope and Definitions | 00:03:27 |
| Economic Operators | 00:07:47 |
| EUDAMED and UDI | 00:05:31 |
| Classification & Conformity Assessment | 00:02:09 |
| Clinical Evaluation and Investigations | 00:19:05 |
| Surveillance & Vigilance | 00:02:12 |
| Cooperation | 00:02:15 |
| Data Protection | 00:01:43 |
| Final Provisions | 00:04:44 |
| Conclusions | 00:04:25 |
Exam and Certifications
- Final Test – Medical Device Regulation Roadmap and Regulation
- 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
- Cooperation between the European Commission and new entities
- Data protection requirements
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
- On completion, you’ll earn a certificate by Meditrial, an internationally recognized ISO 9001 certified provider of medical and regulatory education
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