MDR Course for Researchers

Understand how to be compliant with the Medical Device Regulation (MDR) with our MDR Course. This highly interactive, selfpaced e-learning course is written by experts, includes 6 interactive modules and has a duration of 4 hours.

 249.00

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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 researchers involved in clinical trials with medical devices.

The MDR course for Researchers is the self-paced online training solution for clinical research professionals who need to update their knowledge of the Medical Device Regulation. You will get trained on the EU-MDR to align your research and devices 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 training 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 Course for Researchers, 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

[toggles title=”Module: The Basics”]
You’ll learn the following in this module:

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

[/toggles]

[toggles title=”Module: Scope of MDR”]
You’ll learn the following in this module:

  • Timelines in more detail
  • Trial types and articles

[/toggles]

[toggles title=”Module: Submitting”]
You’ll learn the following in this module:

  • Requirements for submitting
  • Before Starting the Trial

[/toggles]

[toggles title=”Module: Safety Reporting”]
You’ll learn the following in this module:

  • Safety

[/toggles]

[toggles title=”Module: Modifications and End of Trial”]
You’ll learn the following in this module:

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

[/toggles]

[toggles title=”Module: Vigilance Reporting”]
You’ll learn the following in this module:

  • Post Marketing Follow-up

[/toggles]

[toggles title=”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

[/toggles]

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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