QUALITY MANAGEMENT FOR MEDICAL DEVICES AND ISO 13485

PUBLIC COURSE / IN-HOUSE COURSE

This 2-day course is specifically tailored to make the requirements of the ISO 13485 as tangible and concrete as possible, so participants can confidently work in an organisation where ISO 13485 requirements apply.

PUBLIC COURSE

Course length
2 days
Upcoming courses
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Course fee (per person)
€ 1190
90-day early bird special
€ 1071

Course description

This course provides an overview to quality management with regards to medical device product development, the requirements of the ISO 13485 standard including the processes and documentation needed.

Topics covered on the course include: the regulatory framework, the quality management system (QMS), documentation pitfalls, risk-based approach, management responsibility, product realization and traceability, complaints and CAPA.

We recommend this course for professionals who work with a quality management system in a medical device organisation where ISO 13485 requirements apply, and those who typically are engaged in supporting QA related tasks such as CAPA, complaints, risk management, documentation and internal auditing.

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Peter Sebelius instructor

Peter Sebelius is a highly esteemed trainer, consultant and entrepreneur in the medical device industry. He is a member of the Joint Working Group that has authored the latest versions of ISO 13485 and ISO 14971 standards.

He has vast ‘hands on’ experience, having developed, amongst other things, a mechanical chest compression device and an ex vivo perfusion machine for lungs. He has received numerous awards including the Great Design Award and the title “This year’s specialist” by Veckans affärer.

Benefits for you

  • Pragmatic quality management course
We have designed this course to be as hands-on as possible with real life examples of how to work, quiz questions and workshops throughout. By the end of the course you will truly understand what you need to do and why.
  • Understand the meaning of the requirements in the standard
Reading the ISO 13485 standard is easy (albeit not particularly entertaining), but understanding the meaning of the requirements and how to implement them in an effective way is much harder. This course gives you the keys to unlocking the meaning of the requirements and the ways you need to work operationally to meet the requirements.
  • Fun and interactive
We pride ourselves on making a topic that could be considered somewhat “dry” and “boring” interesting and even fun. The course has a high pace with a high level of interactivity.

Course programme

Day 1

  • The regulatory framework
  • General safety and performance requirements
  • The standard names
  • Introduction to ISO 13485
  • The Quality Management System
  • Introduction to risk
  • Internal audit
  • What is enough
  • Control of documents and records
  • Documentation pitfalls

Day 2

  • Product documentation
  • Management responsibility
  • Resource management
  • Product realization – Design and Development
  • Product realization – Purchasing
  • Product realization – Manufacturing
  • Traceability
  • Design changes
  • CAPA
  • Complaints

NOTE – The course program structure is subject to change

 

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Frequently asked questions

Yes, the course material includes a course binder with hand-out slides where a majority of the presented content is included.
There is no certification or accreditation for quality management, however the instructor has conducted training in the field for many years and continuously participates in authoring standards such as the ISO 13485 and ISO 14971. This ensures the instructor has access to leading-edge knowledge and information which is the highest qualification available for teaching the course.
The maximum number is 15. With more people on the course, you loose the interactivity and people won’t dare to ask questions.

Yes, you can have the course as an in-house course. Please use the contact form to request a proposal and we will get back to you right away.

There are no pre-requisites but it is helpful to have experience from product development in medical device industry or any other regulated industry or experience from the medical device industry in general.
Yes, but only if you are present 75% or more of the course duration. You also have to be active on the course to be eligible for the certificate.
The course fee is at the top of this page. For more information, please request the course programme by filling out the form.
The date of the next course at the top of this page. For more information about the location and future courses, please request the course programme by filling out the form.
Would you prefer a course held on your premises?
We are naturally happy to hold courses on your premises. Simply contact us to discuss your requirements.
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