Medical Device Regulation (MDR) Implementation Training

Description

The aim of this course is to provide Learners 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.

Objectives

Upon completion of this course, Learners will be able to:

* Identify the links between 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.

Audience

This course is designed for those with a good understanding of Current Medical Directives, the ISO 13485:2016 requirements, terminology used, and requirements to achieve certification. 

Learners attending the virtual training live online will need hardware, internet connection and audio connection for the full duration of the course.