ISO 13485

ISO 13485:2016 for medical devices

The course is aimed at those who work in a medical device or in vitro diagnostic company and want to train in ISO 13485:2016.



ISO 13485 is designed to be used by companies and organizations involved in the design, production, installation and servicing of medical devices and services. Internal and external parties, such as certification bodies, can use ISO standards to support their auditing processes.

This course gives you an overview of ISO 13485:2016. The responsibilities of management and staff in a medical device company and the recommended processes and responsibilities. Changes from the previous edition of ISO 13485 and the link to MDR. After the training, you should have gained knowledge of the standard and the changes in the 2016 version. You also have good knowledge to be able to implement business processes that are adapted to ISO 13485:2016.


Instructor-led course

Our instructor-led courses are carried out by our most sought-after consultants as educators. Classroom days are complemented by online training, so you can still meet others with similar challenges even when you are unable to travel or be away from work.

If instructor-led course dates are missing for the course you want to attend or if you want to customize a course for your specific needs, you can contact us and together we can find the best solution for you.

Most of the instructor-led courses are organized with our partners
Läkemedelsakademin (The Swedish Academy of Pharmaceutical Sciences), Swedish Medtech & Swedish Labtech.

Instructor-led course can be done on request

Dates for planned courses can be found in the calendar or on the right side of this page.


Interactive e-learning

Essentials of

Essentials is for those who want to get a brief overview of a topic without in-depth training and tests. Our Essentials trainings are on average about 15 minutes long and do not include tests/certificates. 

Principles of

Principles is for those who want a basic course in a subject. Provides a good foundation for learning more and includes the "Essentials of". 

Advances of

Advances of is for those who want to gain an in-depth understanding of a topic. Here we recommend that you already have basic knowledge in the area or have completed our "Principles of" training in the area.


During planning

Essentials of ISO 13485
Principles of ISO 13485



No planned courses

Customised course

Are you interested in having this course customised to your company? Contact us!