Online EU MDR 2017 745 Practitioner Training | CQI, IRCA & Exemplar Global Certified

Our Online EU MDR 2017 745 Training Course can take you through the new European Medical Device Regulation, 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 – and it can be completed anytime, anywhere (24/7).

On completion, 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

CQI & IRCA (No. 2378) and Exemplar Global certify our Online EU MDR 2017 745 Training course. Successful completion will entitle each Learner to receive a digital Certificate of Achievement.

• Quality assurance professionals
• Quality Engineers
• Research and design Engineers
• Internal Auditors
• Quality Managers
• Manufacturing Engineers
• Regulatory professionals

• Complete the eLearning modules and obtain 70% or higher in the final assessments (MCQ-based)

Upon registering for this course, each Learner will have 90-days of eLearning access to complete the course, including final assessments.

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 2016 Foundation (FD132) training course or equivalent.

Medical Device 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

There are recommended requirements for each Learner in wishing to complete any of our eLearning 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.

Click here to read the full technology requirements.