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 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 interactive course is aimed at 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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*available for a limited period only
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
- 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
- Relationship to ISO 13485:2016, 90/385/EEC and 93/42/EEC
Module 2: Placing a MD on the market
- Overview of articles 5-9
- Role of the Authorised Representative
- Obligations of Importer, Distributer and Person Responsible for regulatory compliance
- Application of manufacturing obligations to other stakeholders
- EU declaration and CE Marking, Annex IV, Annex V
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.
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