Medical Device Regulation (MDR) (EU) 2017/745 Implementation Training Course
The objective of this course is to provide leaners with knowledge and understanding of the additional requirements within the Medical Device Regulation (MDR) as well as of the current directives (MDD 93/42/EE) and ISO 13485:2016, including the terminology used and the certification requirements.
Course Overview
What you'll learn
Upon completion of this course, learners will be able to:
- Identify the links between EN ISO 13485:2016 (QMS) and MDR EU/2017/745
- Explain how terminology has changed and where gaps require additional work for clients to meet the new requirements
- Define new requirements for proactive post-market surveillance
- Outline the stages of the transition from MDD to MDR so that clients can create individual transition plans
- Define the key deliverables for all economic operators
Learners will need to demonstrate acceptable performance in these areas to complete the course successfully.
On completion of this course, learners will be issued with a “Certificate of Attendance”.
Who This Course Is For
Prior Knowledge
It will benefit learners if they have a knowledge of the following principles and concepts:
- Current Medical Directives
- ISO 13485:2016
- Terminology used
- Requirements to achieve certification
Virtual Course requirements:
To ensure your access to the virtual course and to gain the most out of this training we request all learners have:
- Reliable internet access (High speed)
- Computer with microphone and camera capabilities
Assessment and group activities for this course requires your camera to be turned on. Background effects such as blurring can be used for preserving privacy.
About this course
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