Online EU MDR 2017 745 Training #separator_sa Certified eLearning

Online EU MDR Training for Practitioners | CQI, IRCA & Exemplar Global Certified

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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.

Subject Area
Medical Devices
20 Hours
USD $ 1395.00  per person
Team Pricing
USD $ 5,580.00
CQI & IRCA (No. 2378), Exemplar Global

Learning Objectives

On completion of this Online EU MDR Practitioner Training, successful Learners will have the knowledge needed to:

  1. Explain the history, purpose, and structure of the EU MDR, and the key terminology used throughout the regulation
  2. Identify the types of devices covered by the EU MDR and the rules for classifying these devices
  3. Describe the obligations of the economic operators and the PRRC
  4. Describe the General Safety & Performance Requirements and the key features of a risk management system based on ISO 14971
  5. Describe the contents of the Technical Documentation and the requirements for Post Market Surveillance, Vigilance, and Clinical Data
  6. 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

  •  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


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.