Medical Device Regulation Roadmap And Orientation

$79.00

This lecture presents the roadmap of the new European regulation for medical devices and provides an orientation to navigate all the key changes. Learn all you need to know for a successful transition to the new legislative framework.

  • Course Type: Video Lecture
  • Language: English
  • Level: Advanced
  • Session: year 2020
  • Time: 1 - 3 Hours

Course Breakdown

Section Time
Introduction 00:01:48
Meditrial Expert Speaker and Tools 00:01:33
Key Changes in MDR 00:05:05
MDR Structure 00:05:53
MDR Scope and Definitions 00:03:27
Economic Operators 00:07:47
EUDAMED and UDI 00:05:31
Classification & Conformity Assessment 00:02:09
Clinical Evaluation and Investigations 00:19:05
Surveillance & Vigilance 00:02:12
Cooperation 00:02:15
Data Protection 00:01:43
Final Provisions 00:04:44
Conclusions 00:04:25

Exam and Certifications

  • Final Test – Medical Device Regulation Roadmap and Regulation
  • Certification

Description

What I will learn?

  • MDR Structure and Key changes to the Regulation
  • MDR Scope and Definitions
  • Responsibilities and obligations of Economic Operators
  • EUDAMED and UDI
  • Device classification and Conformity assessment
  • Clinical evaluation and investigations
  • Surveillance and Vigilance
  • Cooperation between the European Commission and new entities
  • Data protection requirements

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
  • On completion, you’ll earn a certificate by Meditrial, an internationally recognized ISO 9001 certified provider of medical and regulatory education

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