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.
Learning Objectives
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
Course Content
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Who Should Attend?
- Quality assurance professionals
- Quality Engineers
- Research and design Engineers
- Internal Auditors
- Quality Managers
- Manufacturing Engineers
- Regulatory professionals
Entry Requirements
Before completing this course, each Learner should have the following prior knowledge:
ISO 13485
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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
Assessment Methodology
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
Certification
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
4.6
Average Rating
239 global ratings
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very much useful and informative
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Great course and very detailed!
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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.
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Complete and up to date course. Useful to understand the MDR structure
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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.
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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.
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Very good course.
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The self guided written instruction were the most useful it was hard to take notes for the instructional portions
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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