Online Basic Overview of EU Medical Device Regulation/MDR 2017/745 Course

★★★★★
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  • Course Area:

    Medical Devices

  • Continuing Education Units (CEUs):

    0.2

  • Course Duration:

    2 Hours

  • Accreditation:

    CQI and IRCA approved training partner
  • Format:

    Online & Self-Paced Course

  • Individual Pricing:

    295.00 per person

  • Team Pricing:

    Need more! Call us

Explainer Video for EU MDR Basic Overview Course

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

Watch Video

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

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 basic overview of the European Medical Device Regulation (EU-MDR 2017/745).

Course Certification

This course is fully certified by Comply Guru™ & Meddev Solutions. Successful completion will entitle each Learner to receive a digital Certificate of Completion.

Who should attend?

  • 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.

Assessment Methodology

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)

Course Access & Support

Upon registering for this course, a Learner will be able to avail of the following:

  • Course Access for 30-days
  • Phone & Email Support (Virtual Instructor)

About Meddev Solutions

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.

  • 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

    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.

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