New Medical Device Regulation (MDR) Master Class

$989.00

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.

  • 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.

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