Online EU MDR Training for Practitioners | CQI, IRCA & Exemplar Global Certified
Online EU MDR 2017 745 Training for Practitioners (CQI & IRCA Certified) that takes you through the new European Medical Device Regulation (EU MDR 2017 745), 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 has been specifically designed for Quality & Regulatory Professionals.
Our 20hr eLearning course is a highly interactive way to learn at a time & a pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.
On completion of this Online EU MDR Practitioner Training, successful Learners will have the knowledge needed to:
- Explain the history, purpose, and structure of the EU MDR, and the key terminology used throughout the regulation
- Identify the types of devices covered by the EU MDR and the rules for classifying these devices
- Describe the obligations of the economic operators and the PRRC
- Describe the General Safety & Performance Requirements and the key features of a risk management system based on ISO 14971
- Describe the contents of the Technical Documentation and the requirements for Post Market Surveillance, Vigilance, and Clinical Data
- Explain the Unique Device Identifier requirements and the relationship with EUDAMED
Who Should Attend?
- Quality assurance professionals
- Quality Engineers
- Research and design Engineers
- Internal Auditors
- Quality Managers
- Manufacturing Engineers
- Regulatory professionals
Before completing this course, each Learner should have the following prior knowledge:
Knowledge of the requirements of ISO 13485, which may be gained by completing a CQI and IRCA Certified MD-QMS ISO 13485 Foundation (FD132) training course or equivalent.
Medical Device Quality Management Systems
Knowledge of the following quality management principles and concepts:
- The relationship between ISO 13485 and the EU MDR 2017/745
- Commonly used quality management terms and definitions within ISO 13485 and ISO 9000
- A working knowledge of risk management principles related to the design of a medical device, through ISO 14971
Assessment & Certification
In order to successfully complete this course, each Learner will need to:
- Complete the eLearning modules and obtain 70% or higher in the final assessments (MCQ-based) within the 90-day course license
Our Comprehensive EU MDR Practitioner Training Course is CQI & IRCA Certified (No. 2378). Successful completion will entitle each Learner to receive a digital Certificate of Achievement.
Reviews & Ratings
239 global ratings
very much useful and informative
Great course and very detailed!
CompyGuru has a great self paced course with inclusion of checkpoints in understanding current info before proceeding to the next module. I enjoyed the course and look forward to using ComplyGuru again i the near future.
Complete and up to date course. Useful to understand the MDR structure
This was a very comprehensive course on EU MDR 2017/745. Every aspect of the regulation was taught in a very detailed manner. The frequent knowledge checks and exams after each section ensured that the learner is really grasping the concepts and not just navigating through the course. I would highly recommend this course to anyone seeking to gain in-depth knowledge of the EU-MDR.
If you are an independant contributor this course is good. If you are a Manager or Director this course will take up a significant part of your time to complete.
Very good course.
The self guided written instruction were the most useful it was hard to take notes for the instructional portions
This course was so well done. It was a mix of learning between audio, reading and knowledge checks. I found it brilliant and would highly recommend it to anyone