Quality Training

Comprehensive EU Medical Device Regulation (EU-MDR 2017/745) Practitioner

Objectives

The CQI, IRCA & Exemplar Global certified Comprehensive EU Medical Device Regulation (MDR) 2017/745 Practitioner Course which can take you through the 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. This course will focus on the overview & application – it isn’t just a simple ‘read and understand,’ it is a practical ‘how to’ guide, which you can actually use immediately.

Delivered by Comply Guru.

Content includes

Format:
· On Demand Training (Self-Paced Learning – Anytime, Anywhere 24/7)
· Duration: 20hrs

Course Access & Support
Upon registering for this course, a Learner will be able to avail of the following:
· Course Access for 90-days
· Phone & Email Support (Virtual Instructor)

Learning Objectives:
On completion, 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

Qualification

Certification:
This Comply Guru course is certified by Exemplar Global under the RTP Program, plus this course is certified by CQI & IRCA (No. 2378).
Successful completion will entitle each Learner to receive a digital CQI, IRCA & Exemplar Global Recognized Certificate of Achievement.

Assessment Methodology:
Complete the online, self-paced course modules and obtain 70% or higher in three final assessments (MCQ-based Assessments)
This course is available in three parts, each with its own final assessment at the end of each part.
A Learner may only progress to the next part upon successful completion of the previous part as the learning is progression based (sequential).

Upcoming dates:

No training dates available at the moment.