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
