ISO 13485 and Quality Management for Medical Devices / Internal Auditing
Introduction
The course will give you an introduction to the ISO 13485 and the knowledge on how to implement a quality management system (QMS) in line with ISO 13485. In addition you will get an insight into the audit process as required by the standard.
The course consists of two parts – ISO 13485 and the related audit process.
The purpose of the course is to provide documented competences in the ISO 13485:2016 standard, and to provide understanding of the audit process.
The course will include class discussions, real life examples and practical exercises as time allows.
Target group
Employees needs an introduction to the planning, implementing and maintenance including auditing of an ISO 13485 quality management system.
This could be employes working in companies that are ISO 13485 certified or are on the way to becoming ISO 13485 certified or are suppliers to companies, which are ISO 13485 certified.
No pre-knowledge and experience with the ISO 13485 standard is required.
Course format
The course consists of two parts.
Part 1: Quality management for Medical Devices and ISO 13485 (2 days)
Part 2: Internal auditing for medical device companies and ISO 19011 (1 day)
Part 1 is offered as an independent course. It lasts 2 days and covers the ISO 13485:2016 standard.
The entire course lasts 3 days and ends with a written multiple choice test.
Course language
The course is in English.
Trainers
Bolette Nordby
Senior Consultant and Owner, NOEI Medical Device Consulting
Bolette Nordby works with quality and compliance for medical devices and drug-device combination products. On this course, she helps participants translate the requirements of ISO 13485 into a practical, risk-based quality management system that can be implemented, maintained and continuously improved across the organisation.
Liselotte Blond Sørensen
Senior Consultant and Partner, Danish Medical Devices Consulting ApS
Liselotte Blond Sørensen is an experienced lead auditor for ISO 9001 and ISO 13485 quality management systems. On this course, she introduces the key ISO 13485 requirements and their practical application in a quality management system for medical devices. Participants gain an understanding of QMS documentation, management responsibilities, risk-based processes, design and development, supplier management, production, post-market surveillance and CAPA. The course also introduces internal auditing as a tool for assessing compliance and QMS effectiveness.
What previous participants said
Contact
Select date
9-11 november 202610-12 maj 2027
3-5 november 2027
9-11 November 2026 - at 09:00 - 16:30
Price ex. VATLatest Registration
2 November 2026
Latest Cancellation
19 September 2026
Bøge Allé 5, 2. th
2970 Hørsholm
View Program
Terms
In-house Courses
MedTech Academy offers in-house training courses tailored to your specific needs. Courses can be based on our open programme or developed specifically for your organisation. You choose the focus, format and timing – and work with your own cases in a confidential setting. Contact us to discuss the possibilities.
Do You Have a Specific Competency Need?
We continuously develop and update MedTech Academy’s course portfolio to match the current needs of medical device companies. If you are looking for a specific course, or if you are unsure which course is the right fit for you and your organisation, you are always welcome to contact us.
Berit Munkebo
Head of Development
bm@medicoindustrien.dk
Academy News
Academy News is Medicoindustrien’s weekly newsletter with a complete overview of upcoming and newly developed courses from MedTech Academy. The newsletter provides a quick overview of new dates, upcoming sessions and current course topics for professionals working with medical devices.