In-Depth MDR Online Course
Medical Device Regulation (MDR) Foundation Course (EU) 2017/745
Available September 1st
Pre-order now for a 20% discount
with tutor support when you need it
No additional fees
No membership or assessment fees
We have partnered with Comply Guru, an expert leader in online training to make our MDR course available as an eLearning course.
Your course is fully online.
You'll cover 10 units:
- Course introduction
- Introduction to the EU MDR
- Medical Devices covered by the EU MDR
- Placing a Device on the Market
- Device Classification
- Routes to Conformity
- GSPR & Risk Management
- Clinical Evaluation
- Technical Documentation
- Post Market Surveillance & Vigilance
▪ Learn at your own pace and set your own schedule
▪ Fully certified by Comply Guru and Meddev Solutions
▪ Progress onto the 16-hour EU MDR Foundation Course
▪ Learn practical skills you can implement into your organisation immediately
For full details of what you’ll learn, download our course overview.
You’ll be assessed through one online multiple choice exam. In order to successfully complete the course, you will need to obtain a grade of 70% or higher. Successful completion will entitle you to receive a certificate of completion.
Working knowledge of medical device quality management systems (QMS) and risk management is recommended prior to completing this course.
If you don't have this, you can begin with the 2-hour MDR Overview, which has no entry requirements.
This course is most suited to individuals who are responsible for or involved with the implementation or maintenance of a medical device QMS, Including but not limited to:
- QA Professionals
- Quality Engineers
- Research & Design Engineers
- Internal Auditors
- Quality Managers
- Regulatory Professionals
- Manufacturing Engineers
Looking for a beginners course? View our 2-hour MDR Overview course
The MDR Guidebook.
Your 'go-to' reference and tool kit for ensuring MDR compliance.
This guidebook contains a number of useful tools and tables to guide you through the MDR, such as:
device classification and their differences from the MDD
QMS requirements and how they align with ISO 13485
technical documentation requirements
clinical data requirements, including a handy checklist
general safety and performance requirements tables
annex and article guide
Receive 25% off with each course enrolment!