MDR Course for Clinical Research in Europe

Are you involved in clinical trials with medical devices in Europe? Understand how to align your medical device research with the Medical Device Regulation (MDR) with our MDR Course for Clinical Research in Europe. This highly interactive, self-paced e-learning course is written by experts, includes 6 interactive modules and has a duration of 4 hours.

€ 199.00

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LEARNING OBJECTIVES

  • Understand why the MDR was established
  • Understand the applicable regulatory framework for different research types
  • Understand the impact of the MDR on medical device research, and how it differs from the Medical Device Directive it replaces
  • Understand the clinical trial submission requirements and the assessment process
  • Understand the safety and vigilance requirements
  • Reference will be made to ISO 14155 and ISO13485 where applicable

 

DESCRIPTION

Compliance with the Medical Device Regulation (MDR) is critical for those who take part in clinical trials with medical devices. This online course covers the areas of the MDR applicable to clinical research.

The MDR Course for Clinical Research is the self-paced online course solution for investigators and clinical research professionals who need to learn about the impact of the Medical Device Regulation to their research. Via an interactive storyline, you you will learn how to align your current research with the new requirements of the Medical Device Regulation.

The e-learning is the best choice for those who like the flexibility of online learning at their own pace and time. This course translates the MDR framework to the current practice in European research institutions and gives you the tools to directly implement the knowledge in your daily practice.

  • EU MDR Certificate
  • Efficient and interactive learning
  • Easy accessible via smartphone, tablet or desktop
  • Self-paced and modular

The course consists of 6 online course modules and represents a total workload of 4 hours. The modules are divided into chapters of 10 to 40 minutes. After you have completed the modules and the knowledge test of the MDR for Clinical Research course, you will receive an EU MDR Certificate.

All training courses include one-year access to the online training and updates.

Enroll now to get started with the online learning modules on your smartphone, tablet or desktop computer.

 

COURSE CONTENTS

Module: The Basics

You’ll learn the following in this module:

  • Changes due to MDR
  • The General Timelines
  • Impact for you

Module: Scope of MDR

You’ll learn the following in this module:

  • Timelines in more detail
  • Trial types and articles

Module: Submitting

You’ll learn the following in this module:

  • Requirements for submitting
  • Before Starting the Trial

Module: Safety Reporting

You’ll learn the following in this module:

  • Safety

Module: Modifications and End of Trial

You’ll learn the following in this module:

  • Modifications
  • Temporary Hold or (Early) Termination of a Trial

Module: Vigilance Reporting

You’ll learn the following in this module:

  • Post Marketing Follow-up

Module: Knowledge Test

The knowledge test includes:

  • Knowledge test of 25 questions
  • Feedback per question (afterwards)
  • 3 attempts
  • Available in English and Dutch
  • Online certificate with a score of 80 or higher

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Learn anytime, anywhere

Learn at your own pace on your smartphone, tablet or desktop. You will have one year of access to the training and resources so you can look up information even after you’ve completed the course.

Learn Continiously

Continuous Learning can both improve clinical research quality and ensure a motivated research team. You’ll benefit from better knowledge retention and reduced risks.  We When a regulatory update is announced, we update the training modules and notify you, so that you can take the updated module and earn a new GCP certificate.

Earn your gcp certificate

With our courses, you can earn and maintain your vital industry-recognized certificate. In your GCP Passport, you can now see exactly which version of a training module you were most recently trained on. This documentation in combination with the changelog will inform auditors, managers, and inspectors of the associate’s compliance with current regulations.

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