Online & Self-Paced Basic Overview of EU Medical Device Regulation (MDR 2017/745) 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.

If you are not 100% sure or would like to refresh your knowledge, then this course is most definitely for you. Our online interactive course is aimed at anyone working in the medical device industry sector who is looking for a general overview of the EU MDR.


Course Snapshot

  • Course Duration:

    2 Hours
  • Format

    Online & Self-Paced Course
  • Accreditation

    CQI and IRCA approved training partner This course is certified by Comply Guru & Meddev Solutions
  • Delivery Options & Discounts

    • Online & Self-Paced Only
    • Discounts Available for 10+ Licenses
  • Price

    225.00
  • Fee Includes

    • Course Access for 30 days
    • Virtual Instructor Assistance – Phone & Email Support
A video about Comply Guru's online training library for compliance and certification

Explainer Video for EU MDR General Overview Course

In this video, we provide an overview of what our EU MDR General Overview Course is all about including what it covers, who should attend plus some BONUS footage from a short Q&A session!

Start Date Location Cost Hours Actions Volume License
Anytime

Anywhere

$225.00
2Hours

The MDR Guidebook from Meddev - Get 25% Off

For anyone involved in ensuring compliance with the EU MDR, this Guidebook is the ‘go-to’ reference and tool kit, intended to be your companion to reference time and time again. It contains a number of useful tools and tables to guide you through the MDR & with each online course purchase, you receive a 25% off discount code!

  • Module 1: Introduction to the EU-MDR (Online & Self-Paced)

    • History of MD scandals
    • Purpose of EU-MDR
    • Structure of EU-MDR
    • Definitions
    • Medical devices covered by EU-MDR
    • Key changes introduced by EU-MDR
    • Timelines for transition

  • Module 2: Placing on the market (Online & Self-Paced)

    • Overview of articles 10, 11, 13-15
    • Role of the Manufacturer, Authorised Representative, Importer, Distributer and Person Responsible for Regulatory Compliance
    • Overview of articles 5, 19, 20
    • Brief overview of Classification, Conformity assessment, EU declaration of conformity and CE Marking

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:

  • Anyone working in the Medical Device Industry
  • Quality assurance professionals
  • Quality Engineers
  • Research and design Engineers
  • Internal Auditors
  • Quality Managers
  • Manufacturing Engineers
  • Regulatory professionals
Note: This course is not just for Regulatory Professionals and a suitable course for anyone wishing to gain a general overview of the EU MDR.

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

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

    Rod has worked in Pharmaceutical and Medical Device sectors for over 19 years and holds a degree in engineering.

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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.

Some Companies that have used Comply Guru™

The Numbers - How We Are Doing

  • 100%

    Our Pass Rate

  • 100%

    Would Recommend Comply Guru

  • 99%

    Gave us 4/5 Stars or higher Overall Training Experience

  • 95%

    Would Recommend Online or Blended Training over Classroom Training

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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