Access Meditrial Academy to learn quickly and easily the details of the new Medical Device Regulation (MDR) 745/2017. Everything you need to know about the MDR and how to apply it to devices and companies.
New Medical Device Regulation (MDR) Master Class
$989.00
- Language: English
- Level: Advanced
- Time: 3 – 5 Hours
- Special: BUNDLE & SAVE!
- Session: 2022
Course Breakdown
| Sections |
|---|
| MDR Courses Introduction |
| New MDR Overview and Timelines |
| MDR Common Specifications |
| MDR Conformity Assessment Procedures |
| MDR European Representative Obligations and Management |
| MDR EUDAMED, European Database for Medical Devices and IVDs |
| MDR The new European UDI System part 1 |
| MDR The new European UDI System part 2 |
| MDR Requirements for Device Labelling |
| MDR Requirements for IFU |
| MDR Post-market Surveillance |
| MDR Post-market Clinical Follow-up |
| MDR Vigilance System |
| MDR Technical Documentation |
| Medical Device Software, AI, Machine Learning |
Exam and Certifications
- Final Test for MDR overview and timelines Tutorial TR-EU-029
- Final Test for Common Specifications Tutorial TR-EU-040
- Final Test for European Authorized Representative Tutorial TR-EU-025
- Final Test for EUDAMED, the European Database for Medical Devices and IVDs Tutorial (EU-103-F)
- Final Test for The new European UDI system Tutorial TR-EU-033
- Final Test for Requirements for device labeling Tutorial TR-EU-034
- Final Test for Requirements for IFU Tutorial TR-EU-035
- Final Test Post-Market Surveillance Tutorial TR-EU-036
- Final Test of Post-Market Clinical Follow-up Tutorial TR-EU-037
- Final Test for Post-market vigilance of medical devices Tutorial TR-EU-038
- Final Test for Requirements for Technical Documentation Tutorial TR-EU-039
- Final Test for Medical Device Software, AI, Machine Learning Tutorial TR-EU-043
Description
What I will learn?
Meditrial Academy helps device manufacturers to navigate the European regulation changes. Explore the Academy to learn quickly and easily the details of the MDR and its impact on your business.
