Medical Device Regulation- One Day Training Course

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The Medical Device Industry is currently transitioning from the Medical Device Directive (MDD) 93/42/EEC to the Medical Device Regulation (MDR) 2017/745. As an industry we need to progress through this transition period in order to keep our products on the European Market and retain our CE mark. It is important therefore that we understand the MDR requirements and the key changes this entails for our products so that we can navigate through this change.

This course will look at steps involved in the CE marking process through the MDR (what remains the same, what has changed) as well as other key changes that are required. This course will also link the ISO 13485:2016 quality management system (QMS) requirements to the MDR QMS requirements but emphasizing the importance of the MDR as a legal requirement. This course will break down the MDR requirements into something more manageable and participants will gain the skills to be able to apply the requirements to their own products and understand the language used within the document.

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This course will have specific focus on the MDR 2017/745 and key areas that the medical device industry are currently transitioning through. This includes:

Parties Involved
Key Elements & high-level overview of the MDR
Guide to the CE Marking Process
Medical Device Regulation Classification including Classification Exercises
Conformity Assessment Route Options
Safety & Performance Requirements
MDR QMS requirements. Linking them to the ISO EN 13485:2016 requirements (similarities & deficiencies)
Other key changes within the MDR
CE Marking Exercise

NOTE: Please bring a copy of the MDR with you to the course. Only certain elements of the MDR will be provided in the course material due to the content size of the regulation. A free copy can be downloaded from here.

The course is suitable for personnel from medical device manufacturing industries (both legal manufacturers and contract manufacturers) who need to have a working knowledge/understanding of the MDR. It would be of particular interest to personnel who are required to liaise with notified bodies, who need to understand the CE marking process or who are involved in internal auditing.

Participants achieve the following learning outcomes from the programme;

Understand the main elements & structure of the MDR
Have a working knowledge of the relevant key CE Marking Articles & Annexes within the MDR.
Classify devices according to the MDR
Understand the conformity assessment route options
Understand all the steps involved in the CE marking process
Appreciate what is entailed within the safety & performance requirements
Understand how the MDR QMS requirements and ISO EN 13485:2016 QMS requirements link together (similarities & deficiencies)
Be aware of the key changes within the Medical Devices Regulation
Identify guidance documents available

John Lafferty

John Lafferty is a Quality professional with over 25 years expe...

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Kevina O’Donoghue

Kevina takes great pride in the training she delivers. She unde...

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In-House Courses
The Course Tutor will contact your organisation in advance. In-house courses can be customised to meet your organisation’s specific requirements.

NOTE: This course can be coupled with the ISO 13485:2016 training program to run onsite as a two-day programme.

Course Manual
Delegates will receive a very comprehensive course manual.

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Snapshot

Course Code

LS026

Duration

1 training day

Public Price

Virtual Training: €395

(includes course documentation).

Delivery Mode

This programme is delivered by Classroom, Virtual Training, or In-Company training

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