Online & Self-Paced EU Medical Device Regulation (MDR) 2017/745 In-Depth Foundation Course

★★★★★
(1 Reviews, Click to view)

Overview

Comply Guru™ are proud to be partnering with Meddev Solutions in bringing to market this comprehensive Exemplar Global certified course on the EU Medical Device Regulation (MDR) 2017/745 – it is the first and most comprehensive online & self-paced course to be released in the world!

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, self-paced Exemplar Global certified course can take you through the regulation, not just from an industry perspective, but also from a Notified Body perspective, which means you get the benefit of understanding what both sides are looking for. This course will focus on the overview & application – it isn’t just a simple ‘read and understand,’ it is a practical ‘how to’ guide, which you can actually use immediately.


Course Snapshot

  • Course Duration:

    20 Hours
  • Format

    Online & Self-Paced Course
  • Accreditation

    CQI and IRCA approved training partner
    This course is certified by Exemplar Global
  • Delivery Options & Discounts

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

    1,195.00 + $95 Exemplar Global Certification Fee
  • Fee Includes

    • Course Access for 90 Days
    • Virtual Instructor Assistance – Phone & Email Support
A video about Comply Guru's online training library for compliance and certification

New! Online EU MDR In-Depth Foundation Course!

In this video, Eoin provides an overview of our new In-Depth Foundation on the EU Medical Device Regulation (MDR) Course – Check it out!


This Exemplar Global certified course is online, self-paced & available 24/7/365

This Exemplar Global certified course is online, self-paced & available 24/7/365

Learn Anytime, Anywhere

Start Date Location Cost Hours Actions Volume License
Anytime

Anywhere

$1195.00
( + $95 Exemplar Global Certification Fee )
20Hours

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 0: Course Introduction (Online & Self-Paced)

    • Accessibility
    • Player Features
    • Course Objectives
    • Course Description
    • Module Structure
    • Assessment
    • Meet Our Partner and Expert
    • Learner Support
    • Available Resources

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

    • History of the EU-MDR
    • Purpose of the EU-MDR
    • Structure of EU-MDR
    • Key Terminology
    • Key EU-MDR changes
    • EU-MDR Timelines for transition

  • Module 2: Medical devices covered by EU-MDR (Online & Self-Paced)

    • What is a device?
    • Devices in scope
    • Devices out of scope
    • Non-Medical devices

  • Module 3: Placing a Device on the Market (Online & Self-Paced)

    • Overview of Chapter II
    • Articles 5-9
    • Economic Operator & PRRC Responsibilities
    • Articles 16-24

  • Module 4: Device Classification (Online & Self-Paced)

    • Overview of Annex VIII
    • Class Types
    • Classification Rules

  • Module 5: Routes To Conformity (Online & Self-Paced)

    • Overview of Conformity Annexes
    • Annex IX
    • Annex X
    • Annex XI
    • Custom Made Devices
    • Notified Body Articles & Annexes

  • Module 6: GSPR & Risk Management (Online & Self-Paced)

    • Overview of Annex I
    • Chapter I General Requirements
    • Risk Management (ISO 14971, Chapter II Design & Manufacture
    • Chapter III Device Information

  • Module 7: Clinical Evaluation (Online & Self-Paced)

    • Overview of the Clinical Evaluation requirements including Article 61-62 and Annex XIV

  • Module 8: Post Market Surveillance & Vigilance (Online & Self-Paced)

    • Overview of PMS Articles 83-86
    • Overview of Vigilance Articles 87-89

  • Module 9: Technical Documentation, UDI and Eudamed (Online & Self-Paced)

    • Annex II and Annex III Technical documentation
    • Unique Device Identification (Annex VI)
    • UDI Timelines
    • Overview of Eudamed

Exemplar GlobalThis course is certified by Exemplar Global under the RTP Program.

In order to successfully complete the course, each Learner will need to obtain a grade of 70% or higher in three final assessments. This course is available in three parts, each with its own assessment. Successful completion will entitle each Learner to receive a certificate of completion.

  • A very positive experience, the design of each program is on the money! The content is of a high standard and has the right match of clarity and detail. The delivery of the content is very smooth and professional and conveys all that is necessary for the participant to gather the information that is necessary to meet the objectives. As a quality/regulatory professional with over 20 years experience and a MSc in Medical Technology Regulator Affairs, I fully endorse Comply Guru as a preferred supplier of Quality/Regulatory training.

    Brian O'Connell | September 28, 2020

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, self-paced course modules and obtain 70% or higher in three final assessments (MCQ-based Assessments)
  • This course is available in three parts, each with its own final assessment at the end of each part. A Learner may only progress to the next part upon successful completion of the previous part as the learning is progression based (sequential).
  • Rod Beuzeval

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

    Read More

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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