ISO 13485:2016 & The Medical Devices Regulation (CE Marking Process)

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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 assess... Read More

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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What's covered?

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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.

Who should attend?

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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.

What will I learn?

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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

Who are the tutors?

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How do we train and support you?

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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.

Share this Programme

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Duration
2 training days
Course Times
9.00am - 5.00pm
Price
€850

(includes course documentation, lunch and refreshments).

Delivery Mode
This programme is available In-House and on certain Public dates

What They SayWhat They Say

The tutors’ knowledge very high, she could relate very well to our company

– Sheila Judge, Account Manager, Trulife Ltd

ISO 13485:2016 & The Medical Devices Regulation (CE Marking Process)

Duration: 2 daysPublic Price: €850
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  • 29 - 30 Nov 2017
    Sorry, this date is full – please contact SQT to add your name to a waitlist.
  • 07 - 08 Feb 2018
    Location: Dublin Book Date