Online General Overview of EU Medical Device Regulation (MDR) Course
Comply Guru™ are proud to be partnering with Meddev Solutions in bringing to market this exciting new online (self-paced) course!
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, self-paced course is perfect for anyone working in the medical device industry sector who is looking for a general overview of the EU MDR.
- 2 Hours
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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
- 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.
I really enjoyed the course as it was well presented in a nice format. The balance of slides and course contributor was about right.
Sean Cunney | April 5, 2020
All levels of learner is catered for and no unneccessary use of complicated language. Straight and to the point.
Karen Conway | April 4, 2020
Good some computer glitches at the start.
Martin Crehan | April 3, 2020
This is a great course. The use of videos and handbook make the course easy to follow.
Melody Labrune | April 3, 2020
A very good experience overall with respect to content delivery and interaction. I would definitely use this online training platform again.
Julie Whelan | April 3, 2020
The training experience was satisfactory as a tool to provide introductory training to a subject matter I could see this being used for health and safety and induction type training where test of understanding are needed and evidence of completion of training is required. I am undecided as to whether online training could replace classroom training for some subjects however as it does not support sharing of participants current challenges and the two way interaction and discussions that classroom training facilitates.
Theresa Jeary | April 3, 2020
I really enjoyed the way the course was delivered. The interactive slides where you need to click buttons in order to obtain further information meant you got to go through the course at your own speed. The presentation slides and video presentations were short and to the point the information was appropriately spread across multiple slides without it feeling like a really long presentation.
Aoife Gunning | April 3, 2020
With the current situation in the workplace online training is the way to go. This training is presented very professionally and easy for the user to navigate through.
Brendan McKeon | April 2, 2020
Overall training with Comply Guru is very good and I would recommend to others
Amy O'Mahony | April 2, 2020
I really enjoyed completing training online and found it very informative. I thought it was very engaging and that at no time did I feel bored. I also like the efficiency of this type of training rather than the classroom training.
Orlagh Doyle BioMed | April 2, 2020
Very good excellent mix of content videos and assessments
Brendan McLaughlin | April 2, 2020
its one of the better ones I have done online. The interaction is brilliant and keeps the user engaged. The explanation of everything was fantastically simple and understandable.
Ruth Hyland | April 1, 2020
I thought this course was a good overview of the MDR it provided a basic understanding of some new terms defined responsibility etc. It would be good first step for anyone with very little knowledge of the MDR.The course did not go into great depth in any area and i personally would have preferred more detail in items e.g. IFU changes- what are the main changes or clinical data what are the main changes. This would then obviously have moved it to the next level of understanding.The online platform itself i thought was very good- the fact that the information was presented in different ways would help keep trainee attention and the ongoing assessment helps reinforce points- this i think could be very beneficial in longer course were its difficult to keep trainee attention.
Charles Daly | April 1, 2020
I enjoyed the design and set up the explanations in the beginning were very good. As noted above I would have enjoyed a bit more information in a bit more detail. A very good course for someone new to the MDR trying to navigate the document adding just a reference to where in the MDR the information can be found - like financial liability of the auth. rep for example would make it fun for someone with a copy of the MDR while doing the course.
Daniela ARCONE | March 31, 2020
The Training Program is very well designed. I thoroughly enjoyed doing the course. The sequence is logical. the assessments were at the right points.
Dr. Anita Joshi | March 30, 2020
The content of the course is exceptional and is at the required pitch to satisfy this Managers and professionals who require an overview of the MDR 2017745 with respect to reasons for timelines relationship to existing MDD the transition period CE marking and associated requirements including Declaration of Conformity and contents of MDR. It would also be of great benefit to those within RAQAQC who are tasked with working in preparation for the MDR but who lack a general overview. This training is the ultimate one stop shot. I would and will highly recommend the straining to my contacts in the Medical device and combination product sectors. Well done I eagerly await the next offering from Comply Guru and their MEDDEV Solution Partners
Brian O'Connell | March 27, 2020
Really clear delivery of content. Interactive user assessments work really well to keep trainee engaged.
Anne-Marie Gannon | March 27, 2020
Excellent training course very informative and clear
Elena Feeney | March 26, 2020
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
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 RequirementsThe 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 SystemsWindows 7/10, Mac OSX Sierra, iPad IOS10
Mobile DevicesComply 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 SpeedWe 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
Recommended SettingsWe recommend that the following settings are enabled:
- Pop-ups (in both Internet Browser and security software)
- Latest Version of Adobe Flash Player
- Latest Version of Adobe Acrobat Reader