MDR Course for Clinical Research in the Netherlands

Are you involved in clinical trials with medical devices in the Netherlands? Understand how to be compliant with the Medical Device Regulation (MDR) with our MDR Course for Clinical Research in the Netherlands. This highly interactive, selfpaced e-learning course is written by experts and includes the Dutch guidelines by the CCMO. It 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 MDR articles for different research types
  • Understand the applicable regulatory framework in the Netherlands
  • Understand the impact of the MDR on medical device research in the Netherlands, and how it differs from the Medical Device Directive it replaces
  • Understand the clinical trial submission requirements and the assessment process of CCMO and Ethics committees
  • Understand the safety and vigilance requirements according to IGJ
  • 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 in the Netherlands and includes guidelines by the CCMO, IGJ and Ministry of VWS. It includes explanation of the legislative framework in the Netherlands. The MDR Course for Clinical Research in the Netherlands is the self-paced online course solution for clinical research professionals who need to update their knowledge of the Medical Device Regulation. Via an engaging storyline, you will get trained on the EU-MDR and requirements by the competent authorities and ethics committees in the Netherlands 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 Dutch research institutions and gives you the tools to directly implement the knowledge in your daily practice.

  • 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 Course for Clinical Research in the Netherlands, you will receive a MDR Certificate. All training courses include one-year access to the online course 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, incl CE & Classification Tool of CCMO
  • Transitional period
  • 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
  • Submission of PMCF and other research

Module: Safety Reporting

You’ll learn the following in this module:

  • Safety reporting

Module: Modifications and End of Trial

You’ll learn the following in this module:

  • Modifications
  • Temporary Hold or (Early) End of 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

Related products

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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