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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.

Description

Why take this course

The new MDR 2017/745 will be enforced on May 26, 2021. That will result in more complex rules that will impact medical device manufacturers, operators, health professionals, and the public. This Meditrial Course examines the fundamental concepts of MDR and clarifies the impact of this regulation on medical device industry, conduct of clinical trials and market entry process in Europe.

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

 

TOPICS

  • 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)

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

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