Online EU MDR 2017 745 Practitioner Training | CQI & IRCA Certified
★★★★★4.6 out of 5225 global ratings
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Online EU MDR Practitioner Training (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.
Why Choose eLearning for EU MDR Practitioner Training?
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.
Course Format & Content Breakdown
This Online EU MDR Practitioner Training course is available via eLearning (24/7) offering you the most convenient & flexible way to learn online, anytime, anywhere.
It is important to note that the exact time it takes to complete the eLearning modules will vary based on current knowledge, experience, and learning style.
eLearning Modules
During the eLearning modules, each Learner will cover the following:
History of the EU MDR
Purpose of the EU MDR
Structure of EU MDR
Key Terminology
Key EU MDR changes
EU MDR Timelines for transition
What is a device?
Devices in scope
Devices out of scope
Non-Medical devices
Overview of Chapter II
Articles 5-9
Economic Operator & PRRC Responsibilities
Articles 16-24
Overview of Annex VIII
Class Types
Classification Rules
Overview of Conformity Annexes
Annex IX
Annex X
Annex XI
Custom Made Devices
Notified Body Articles & Annexes
Overview of Annex I
Chapter I General Requirements
Risk Management (ISO 14971)
Chapter II Design & Manufacture
Chapter III Device Information
Overview of the Clinical Evaluation requirements including Article 61-62 and Annex XIV
Overview of PMS Articles 83-86
Overview of Vigilance Articles 87-89
Annex II and Annex III Technical documentation
Unique Device Identification (Annex VI)
UDI Timelines
Overview of EUDAMED
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
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 2016 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
EU MDR Practitioner Training 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
EU MDR Practitioner Training Certification
Our Comprehensive EU MDR 2017/745 Practitioner Training Course is CQI & IRCA Certified (No. 2378). Successful completion will entitle each Learner to receive a digital Certificate of Achievement.
Technology Requirements
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.
Read full technology requirements
Terms & Conditions
In registering for this course, each Learner and/or Customer expressly acknowledges that they have read, fully understood and agreed to be bound by all of Comply Guru’s terms & conditions, including additional licensing agreement. The terms & conditions & licensing agreement can be
read here.
Course Summary
Subject Area
Medical Devices
Duration
20 Hours
Pricing
€ 995.00 per person
Team Pricing
€ 3,980.00 (Book 4, Get 5th Free)
Format
eLearning
Accreditation
CQI & IRCA (No. 2378)
Explainer Video
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Reviews & Ratings
4.6
★★★★★
Average Rating
225 global ratings
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Sandesh Singh
Jan 6, 2023
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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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Charles Mierkiewicz
Nov 20, 2022
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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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Glenn Phelan
Nov 17, 2022
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Very good course.
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Janet Kupec
Nov 14, 2022
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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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Catherine O'Regan
Nov 4, 2022
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Aoife Murphy
Nov 1, 2022
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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
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Jaseem Saqib
Oct 20, 2022
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The experience was very good.
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Chelsea Erasmus
Oct 14, 2022
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This is my third course to complete with Comply Guru and it is one of my favourite online training platforms. Easy to follow modules with great detail.
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Sergio DiCicco
Oct 12, 2022
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Training was very informative covering all pertinent aspects of EUMDR
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Maeve Hegarty
Oct 7, 2022
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Comply guru staff were extremely accommodating and swiftly helpful. I have never done a course where someone has been so quick to get back to me and also to give me some support with extra time due to travelling.