IIRF Online > Business > Industry > Medical Device Development > Practical Regulatory Affairs 2020 - European Medical Devices
Practical Regulatory Affairs 2020 - European Medical Devices by Udemy
A practical course discussing the EU Medical Device Regulation (MDR) in real-world situations
Course Highlights
- Learn about the new EU Medical Device Regulations and how it will impact different medical devices.
- Understand how to obtain CE Marking under the Medical Device Regulations.
- Complete real-world examples and exercises to apply the Medical Device Regulations to mock medical devices.
Skills you will learn!
Curriculum
2 Topics
Introduction and Scope
Instructor Tips
5 Topics
MDD IVDD and AIMDD
Change is Coming
Medical Device Regulations (EU MDR 2017/745)
Key changes in the MDR
The MDR Enforcers
8 Topics
MDR Regulatory Pathway Overview
Medical Device Assessment
Medical Device Assessment
Device Classification Basics
Device Classification Annex VIII
Practice Exercise: Device Classfication
Walk-through: Device Classification
Conformity Assessment Route
3 Topics
Annex IX Conformity Assessment Route
Quality Management Systems (QMS)
Harmonized Standards and Common Specifications
9 Topics
Technical Documentation Overview
Device Description
Device Labeling and UDI
Device Design and Manufacturing
General Safety and Performance Requirements (GSPRs)
Benefit Risk Analysis
Product Verification and Validation
Post-Market Surveillance (PMS) Technical Documentation
Technical Documentation Summary
5 Topics
Declaration of Conformity
DoC Assignment
Notified Bodies and CE Marking Procedure
EUDAMED
MDR Timelines and Transitions
1 Topic
Final Tools
Practical Regulatory Affairs 2020 - European Medical Devices
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