The Medical Devices Directives Training

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This programme is available In-House and delivered through virtual classroom training. ISO EN 13485:2016 is the global Quality Management Systems Standard used by medical device manufacturers to meet certain requirements to support the safety and eff... Read More

This programme is available In-House and delivered through virtual classroom training.

ISO EN 13485:2016 is the global Quality Management Systems Standard used by medical device manufacturers to meet certain requirements to support the safety and effectiveness of the products they sell. Notified Bodies can use this standard when assessing whether companies have a QMS, which meets European Regulation requirements. Such an assessment is required where a manufacturer seeks to apply the CE mark. This means that companies must be conversant with ISO EN 13485:2016, the significant aspects of the regulations, relevant guidance standards and the CE mark process.

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Day One has a specific focus on the ISO EN 13485:2016 QMS standard and includes:

Course Objectives & Introduction
Complete Overview of all sections of ISO EN 13485:2016 including a detailed focus on the updates to the standard.

Day Two has a specific focus on the MDR 2017/745 and the CE Marking Process. This includes:

Parties Involved
Key Elements & high-level overview of the MDR
Guide to the CE Marking Process
Medical Device Regulation Classification
Classification Exercises
Conformity Assessment Route Options
Linking the ISO EN 13485:2016 requirements to the MDR QMS requirements
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 who need to have a working knowledge of ISO EN 13485:2016 and 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 requirements of ISO EN 13485:2016 including the updates
Understand the main elements & structure of the MDR
Have a working knowledge of the relevant key CE Marking 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
Understand how ISO EN 13485:2016 QMS and the MDR 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
Course tutor will contact your organisation in advance. In-house courses can be customised to meet your organisation’s specific requirements.

Course Manual
Delegates will receive a very comprehensive course manual.

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Snapshot

Course Code

LS021

Duration

2 training days

Delivery Mode

Available for In-house and delivered through virtual classroom training

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