Online In Vitro Diagnostic Medical Devices Regulation (IVDR) Course

★★★★★

Overview

Comply Guru™ are proud to be partnering with Meddev Solutions in bringing to market this course!

Meddev Solutions Logo-Large

Meddev Solutions are a team of QARA professionals, each with a minimum of 20 years’ experience, working in the medical device industry for both manufacturers and Notified Bodies.

Our online interactive course provides an introduction to the application of the key principles and practices required for the new In Vitro Diagnostic Medical Devices Regulation.

Upon completing this course,  Learners will understand the changes and new requirements of the IVDR.

 

  • 2 Hours
Online In Vitro Diagnostic Medical Devices Regulation (IVDR) Course

Some Companies that have used Comply Guru™

Start Date Location Cost Hours Actions
Anytime

Anywhere

  € 2Hours
  • The following topics are covered on this course:

    • Requirements for manufacturers and economic operators
    • Classification and recognition of devices
    • Risk analysis and trending
    • Safety and performance requirements
    • Routes to conformity
    • EUDAMED
    • The Unique Device Identifier (UDI)
    • Performance evaluation
    • Post-market surveillance and associated reports

This course is fully certified by Comply Guru™ & Meddev Solutions.

In order to successfully complete the course, each Learner will need to obtain a grade of 70% or higher in the final examination. Successful completion will entitle each Learner to receive a certificate of completion.

This course would be targeted at:

  • Quality assurance professionals
  • Quality Engineers
  • Research and design Engineers
  • Internal Auditors
  • Quality Managers
  • Manufacturing Engineers
  • Regulatory professionals

In order to successfully complete this online course, each Learner will need to:

  • Complete the online course modules and obtain 70% or higher in the final assessment (MCQ-based Assessment)

E-Learning System Requirements

The below are the recommended requirements for each Learner in wishing to complete any of our online training courses or modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS)  may be impacted, restricted and may not perform well.

Recommended Operating Systems

Windows 7/10, Mac OSX Sierra, iPad IOS10

Mobile Devices

Comply Guru’s LMS is not available on a mobile app at this time. We recommend using a web browser on a mobile device in completing any online modules. However, if completing any final graded assessment, we recommend completing via a desktop browser.

Internet Speed

We recommend using an internet connection of 256Kbit/sec or faster that will ensure that you can view videos and the online content

Recommended Internet Browsers

  • Google Chrome 32 bit version 50 or later
  • Safari 10 or later
Important Note: add-ons and toolbars can affect any browsers performance. MS Internet Explorer or Edge is not recommended as its not compatible with the LMS and the course functionality will not work properly.

Recommended Settings

We recommend that the following settings are enabled:
  • Cookies
  • Pop-ups (in both Internet Browser and security software)
  • JavaScript
  • Plugins
  • Latest Version of Adobe Flash Player
  • Latest Version of Adobe Acrobat Reader
To view all resources made available within our LMS, you will probably need Microsoft Office (Word, Excel, PowerPoint) or an equivalent (i.e Open Office, Viewer) installed.

Custom Course Development

We can combine leading industry subject matter experts with an experienced eLearning team to help your organization with its compliance training needs.

Want to learn more? Get in touch.

Would you like to know more about our service? We have a dedicated sales team who would be happy to answer any questions that you may have.

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