Is your Clinical Evaluation ready for the MDR? Discover Meditrial e-learning and avoid delays for market access. Meditrial will guide you with easy steps. Learn at your own pace and reach your goals!
After the course, you can take a brief test to receive your certification. Enjoy!
Clinical Evaluation Upgrade to MDR
$79.00
- Course Type: Video Lecture
- Language: English
- Level: Beginner
- Session: year 2020
- Time: 0 - 1 Hour
- Moodle ID: 152
Course Breakdown
| Section | Time |
|---|---|
| Introduction | 00:05:43 |
| Regulatory References | 00:02:36 |
| General Safety and Performance Requirements | 00:04:25 |
| Expert Panel and Relevant Evidence | 00:03:58 |
| Clinical Investigations and Equivalence | 00:04:54 |
| Clinical Evaluation Updates and Clinical Evaluation Report | 00:06:08 |
| Clinical Evaluation Plan Content | 00:04:52 |
| Criteria for Equivalence and Results | 00:01:38 |
| Consultation and Scrutiny | 00:06:04 |
| MDR Periodic Deliverables | 00:01:31 |
Exam and Certifications
- Final Test – Clinical Evaluation Upgrade to MDR
- Certification
Description
What I will learn?
- Clinical evaluation regulatory framework
- Overview of Article 61 of MDR
- General Safety and Performance Requirements
- How to conduct Clinical evaluation: Step by Step
- Notified Body Clinical Evaluation Assessment Report (CEAR)
- What are your periodic deliverables?
Skills I will gain
- Understand the clinical evaluation process
- Learn about the new GSPR and their relevance for medical devices assessment
- Determine which data you need to support the assessment of your device (clinical investigation, literature review, equivalence)
- Assist your organization in setting a strategy for a successful clinical evaluation
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