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

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.


Delivery Mode

  • Customised
    In-House
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What's covered?

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 participate?

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?

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?

John Lafferty

John Lafferty, B. Tech. in Manufacturing Technology, Six Sigma Black Belt, Cert. Training & Continuing Education, Cert. Quality Management, is a Quality professional with over 25 years experience in the medical device and pharmaceutical industry.  John joined SQT as a tutor in 2007.  Prior to that, John spent many years working in the Medical Devices/ Pharmaceutical sectors – the final six years of which were as a Senior Manager of a multinational Medical Devices plant where he managed the Quality and  Regulatory Systems.  John completed his Lean Six Sigma Black Belt training through SQT in 2009 and derives great benefit from applying the techniques that he learned to Risk Management and Validation in a Life Sciences setting.

“It is great to be able to bring this knowledge and the experience gained from ongoing involvement with Life Sciences companies into the classroom,” he says.

John passionately believes that the key to success in Life Sciences Manufacturing is the relentless application of Risk Management, Variation Reduction and Good Validation Practices.  As the SQT tutor for Technical Writing Skills, John believes that good written communication skills are vital for any Life Sciences professional.

One of John’s greatest achievements in most recent years has been the development of the MDSAP and MDSAP Internal Auditor courses in response to demand from SQT’s loyal client base.


Kevina O’Donoghue

Kevina O’Donoghue is a PhD graduate of the National University of Ireland, Galway with 10+ years experience working as a Microbiologist and 7+ years as a trainer, auditor and consultant, she has the expertise to deal effectively with both Cleanroom and Quality related issues. She is experienced in problem solving, reviewing and critically analysing documentation, investigating non-conformances, writing reports, meeting deadlines and working with various teams. She is skilled in dealing with human related issues and has an admirable way of interacting and engaging at an interpersonal level with people at all levels of the business. With the wealth of experience Kevina has accumulated to date working with many different life science companies both nationally and internationally, she can appreciate and identify many similar situations thus allowing her to link examples and communicate clearly and effectively, to ensure understanding.

Kevina is knowledgeable in many different quality and regulatory standards within the medical device, pharmaceutical, laboratory, & healthcare industries, is a strong and experienced auditor consistently challenging systems for compliance in a fair and consistent manner. Her main focus is on improvements rather than non-conformances, giving businesses a clear, objective insight into their current conformance status and constructive feedback on how to improve and ensure business goals are achieved successfully. Her interpersonal skills, allied with her excellent communication skills make her a very effective trainer. Kevina’s outstanding attribute is her ability to motivate learners and enable their learning through sharing her knowledge and work-based experiences, in a simple and easy to understand way.

Kevina is engaging, enthusiastic and very passionate about her work. Confidentiality and professional impartiality are strong values and principles that she works to at all times.


How do we train and support you?

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.

Kevina O’Donoghue

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