Introduction to Medical Device Regulation Roadmap & Orientation

$49.00

This course presents an overview of the new European regulation for medical devices and provides key information regarding new changes within the MDR. Learn all you need to know for a successful transition to the new legislative framework.

  • Course Type: Video Lessons
  • Language: English
  • Level: Beginner
  • Session: year 2020
  • Time: 0 - 1 Hour

Course Breakdown

Section Time
Introduction 00:01:23
Classification of Medical Devices 00:01:50
MDR Definitions for Clinical Investigation 00:02:21
Types of Investigations 00:06:24
Clinical Evaluation and Investigation 00:02:12
Vigilance and Safety Reporting 00:02:47
Timelines and Grace Period 00:05:12
Conclusion 00:03:36

Exam and Certifications

  • Final Test – Introduction to Medical Device Regulation Roadmap & Orientation
  • Certification

Description

What I will learn?

  • Fundamental Concepts regarding the new MDR
  • MDR Scope and Definitions
  • Key changes to clinical trials
  • Responsibilities and obligations of Economic Operators
  • Device classification and Conformity assessment
  • Clinical evaluation and investigations
  • Surveillance and Vigilance

Skills I will gain

  • Understand the principles, framework and procedures described in MDR
  • Learn how MDR regulates the manufacturing and marketing of medical devices in the EU
  • Set a strategy to meet the new requirements and get your product to the market
  • Understand your responsibilities and obligations as a manufacturer, EU representatives, importers and distributors of medical devices Class I to III

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