Online General Overview of EU Medical Device Regulation (MDR 2017/745) Course
Comply Guru™ are proud to be partnering with Meddev Solutions & the Irish Medtech Skillnet in bringing to market this exciting new online (self-paced) course!
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.
About Our Partners
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. Meddev Solutions worked with us in the development of this course, by providing their expertise on the EU MDR and we combined that with our expertise in eLearning.
Irish Medtech Skillnet
As part of Skillnet Ireland, the Irish Medtech Skillnet, established in 2008, actively supports the current and future training needs in the Medical Technology, Pharmaceutical, Biologics and Biopharma manufacturing industries in Ireland. They will be offering funding to companies based in Ireland for this course!
- 2 Hours
Some Companies that have used Comply Guru™
The Numbers - How We Are Doing
Our Pass Rate
Would Recommend Comply Guru
Gave us 4/5 Stars or higher Overall Training Experience
Would Recommend Online or Blended Training over Classroom Training
This course is online, self-paced & available 24/7/365
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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.
Good course for the basic knowledge required.
Fidelma Murphy | July 8, 2020
Michael Galvin | July 7, 2020
Excellent and focused
Astrid Koengeter | June 23, 2020
This is my second online course with in two weeks I was not very sure of online training at first. I can do it at my own pace and go back and review information which for me is very helpful and take notes at my own pace.Thank youMarie Ivers
Marie Ivers | May 20, 2020
This was the first course I completed with Comply Guru. It was easy to follow and the self-paced feature is useful. The support team is also great they resolve issues instantly. As a Health Safety professional I look forward availing of the resources provided by Comply Guru.
Kateryna Anisimova | May 12, 2020
A very good introduction - does exactly what it says on the tin.
Shane Curran | May 10, 2020
The overall training experience was very good the system is very user friendly and everything was very well explained.
Mary Prunty | May 7, 2020
I enjoyed the 2 modules. I found it very informative. It was a good overview of the MDR. The e-learning platform was easy to navigate.
Michelle Reinecke-Quain | May 2, 2020
The training was straightforward and easily followed.
Jason Pigott | April 24, 2020
A very useful training to have a basic understanding of the MDR requirements. Surely suggested for people that has got limited exposure to the MDR.
Alessandro Agosti | April 20, 2020
Comply Guru offer an excellent easy to navigate platform to complete online training. The EU MDR General Overview course provided exactly that giving insight into the changes for organisations and industry.
Jane Scally | April 18, 2020
Well done The course is a good starter to digest the MDR.
Gunther Burgstaller | April 15, 2020
Very professional polished. Excellent video presentations. I liked the quizzes particularly the fact that the structure of the quizzes varied in nature. I also liked the fact that you could expand parts of the course this allows the learner to tailor the course to their own level of knowledge.
Angela O'Sullivan | April 8, 2020
I really liked the way the course was structured and presented. The learning material was broken down into bite-sized chunks and the regular checks to ensure you understood the content meant that you stayed engaged. The combination of recorded tutor clips and animations kept the content really interesting.
Andrew Walker | April 8, 2020
Can regulatory training be fun This course was. I was kept engaged throughout and really enjoyed working my way through the content. The course provided me with a great overview of the new MDR. I would definitely sign up for another course and wouldnt hesitate in recommending Comply Guru to other people.
Louise Barrett | April 7, 2020
This is a very intuitive and easy to follow program
Carol O'Sullivan | April 7, 2020
I found the training course remarkably informative despite the relatively short duration. The regulation is a hugely complex document but following this course Id be confident to move to the next layer of knowledge. The course is marketed as an introduction to the MDR to be fair it almost encourages you to move to the next level.
John Collins | April 6, 2020
I completed this course in one sitting. I was prepared to come back to it over a few days but found once I started into it my plans changed and it was easy to continue. That you can come back to it and resume from where you left off is excellent. Overall this is a well thought out and designed course. The module lengths are good and the quality of the information is well presented. The audio is well-paced and can be easily followed. The course deals with all of the key EU MDR points very well. The general course interaction worked well from screen to screen and the additional videos by the tutor are a great addition. It has easy to use knowledge checks well placed along the way to monitor your progression and evaluate your understanding. The target is to provide an overview of what EU MDR is about and I believe it does this very well.
Tom Healy | April 6, 2020
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
Course Funding Available with Irish Medtech Skillnet
If you are interested in registering for this online program or looking to arrange multiple licenses for your Company and you are based in Ireland, you can contact Michelle Reinecke-Quain at Irish Medtech Skillnet on 061-431802 or email firstname.lastname@example.org to learn about what funding supports are available for this online course!