Online Comprehensive EU Medical Device Regulation/MDR 2017/745 Practitioner Course | Exemplar Global Certified
Comply Guru™ are proud to be partnering with Meddev Solutions in bringing to market this Exemplar Global certified Comprehensive EU Medical Device Regulation (MDR) 2017/745 Practitioner Course – it is the first and most comprehensive online & self-paced course to be released in the world!
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 Duration:20 Hours
FormatOnline & Self-Paced Course
Delivery Options & Discounts
- Online & Self-Paced Only
- Discounts Available for 10+ Licenses
- Course Access for 90 Days
- Virtual Instructor Assistance – Phone & Email Support
This certified course is online, self-paced & available 24/7/365
Exciting Development! An application has been made to CQI & IRCA for Course Certification!
|Start Date||Location||Cost||Hours||Actions||Volume License|
| $1495.00 ||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)
- Player Features
- Course Objectives
- Course Description
- Module Structure
- 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
This course is certified by Exemplar Global under the RTP Program, plus an application has been made to CQI & IRCA for course certification.
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.
I feel quite confident to handle the RA part of my job after this course. I came in with 3/10 knowledge score and would place myself at 7/10 after the course
Prasanna Venkatesh Rangadurai | November 24, 2020
Comply Guru offer interactive learning which was very helpful in training up on the EU MDR. I would definitely recommend their services to a coworker.
Aine Dooley | November 24, 2020
Good quality material supplied. Clear instructions and information given. Very helpful and fast reacting team.
Kateryna Anisimova | November 23, 2020
Experience was good. Exams were difficult
Olive Gunning | November 23, 2020
The material is covered in the course is beneficial to my job. There was a good balance between presentations and exercises. The course was a good learning experience.
Maryna Zhukava | November 20, 2020
I found this course to be very relevant to the needs of practitioners who need to know more about EU MDR. This course maintains the style pacing and delivery of the General Overview course. Again this more in-depth course is well-paced and has well thought out knowledge checks learner interactions and additional supplementary videos by the trainer. This is a recommended course for someone that needs to go further into EU MDR.
Tom Healy | November 19, 2020
The course was great It was wonderful that is was on demand and self-paced Would consider more training through Comply Guru.
Sarah Evans | November 18, 2020
This course was very informative and helped me to have a better understanding of the EU MDR regulations.
Stephana Biggins | November 16, 2020
I found the course itself to be very comprehensive and tutor was very knowledgeable on EU MDR. I like the onlineself paced training as it would be difficult for me to set aside 2.5 days for traditional classroom based training.I have no issue with content or format of this training.
Angela Kelly | November 12, 2020
Thoroughly enjoyed the EU MDR in-depth course lots of learning for it. Speaker in videos very clear and website user-friendly.
Fiona Kirwan | November 10, 2020
I was able to learn and comprehend the information from the course. I had no training on this information prior but did well during the examinations after each course section.
Danielle Wilson | November 3, 2020
I just completed the EU Medical Device Regulation In-Depth Foundation Course. It was my first experience doing an online self-paced course. And I must say I have already enquired about doing more courses with Comply Guru as I am totally pleased with such a delivery method The Comply Guru Team themselves was very helpful and responsive throughout the course duration and addressed all questions I had. If you are looking for a course that would help you to gain the knowledge you need while making it an interactive experience then I recommend you try this one
Iryna Barouskaya | November 1, 2020
The delivery and content of the EU Medical Device Regulation MDR 2017745 In-Depth Foundation Course was excellent. The balance of video to theory was perfect.The course covers enough detail to provide anyone new to the Medical Device regulations with a good understanding of the requirements with good practical examples
Cormac Mac Liathain | October 29, 2020
No additional comments
Kim Tompkins | October 25, 2020
Great experience. Reasonably priced self-paced course. Knowledge checks were very helpful in maintaining the knowledge.
Matthew Fortson | October 16, 2020
This course is a great overview of the MDR for anyone working in the Medical Device industry that wants a detailed introduction to the MDR requirements.
Elaine Lynch | October 14, 2020
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).
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
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