Online & Self-Paced EU Medical Device Regulation (MDR) 2017/745 In-Depth Foundation Course
Comply Guru™ are proud to be partnering with leading EU Medical Device Regulation (MDR) Experts, Meddev Solutions UK, in bringing to market this exciting new online & self-paced course which is the most comprehensive course of its kind available anywhere in the world!
Our revolutionary Exemplar Global Certified EU Medical Device Regulation (MDR 2017/745) In-Depth Foundation 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
- Discounts Available for 5+ Licenses. Request a Quote!
Price995 + €85 Certification Fee
- Course Access for 90 days
- Phone & Email Support
This course is online, self-paced & available 24/7/365
On Demand Training - Learn Anytime, Anywhere
|Start Date||Location||Cost||Hours||Actions||Volume License|
| € 995 |
( + €85 Exemplar Global Certification Fee )
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.
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.
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
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