This course describes key principles of general safety and performance requirements. In this video we will discuss in detail article 56 of IVDR and will give practical advices on how to plan and prepare for the IVDR. Finically, we will explain what is the performance evaluation and which periodic deliverables and when need to be updated accordingly.
In Vitro Medical Device Regulation Roadmap (IVDR)
$49.00
- Course Type: Video Lessons
- Language: English
- Level: Intermediate
- Session: year 2021
- Time: 0 - 1 Hour
Course Breakdown
| Section | Time |
|---|---|
| Introduction to IVDR | 00:02:08 |
| Key Changes to IVDR | 00:03:02 |
| Guidance and Risk Classification | 00:01:25 |
| IVDR Timelines and Grace Period | 00:01:30 |
| Impact on Industry | 00:01:03 |
Exam and Certifications
- Final Test
- Course evaluation survey
- Certification
Description
What I will learn?
In this course, we will cover all the necessary regulatory references. We will discuss in detail article 56 of IVDR. Moreover, you will learn about general safety and performance requirements. We will also explain what is the performance evaluation and step by step we will guide you through its components. At the end, we will highlight your periodic deliverables so you will be aware on what and when needs to be updated.
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