QUALITY MANAGEMENT FOR MEDICAL DEVICES AND ISO 13485PUBLIC 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.
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 is a highly esteemed trainer, consultant and entrepreneur in the medical device industry. He is a member of the Joint Working Group that is revising the 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.
- 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
NOTE – The course program structure is subject to change
Are you interested in taking this Quality Management classroom course? Click on the button to request information for this course.
Frequently asked questions
Do I get a copy of the course presentation?
Yes, the course material includes a course binder with hand-out slides where a majority of the presented content is included.
Is the instructor accredited or certified to give this training?
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.
Can we have the course as an in-house course?
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.
What are the pre-requisites for this course?
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.