The course is organized so that after the course, you have an overview of and insight into the ISO 13485:2016 standard and the legislation regarding medical devices. You gain knowledge and tools so that you can audit according to the standard and the related legislation.
 
The course consists of 3 main elements - legislation regarding medical devices, ISO 13485 and audit.
 
The purpose of the course is to provide documented competences in the ISO 13485:2016 standard, the legislation for medical devices and to provide documented audit competences.
 
The course will include practical exercises.
 
Target group
The target group for the course is employees who themselves are subject to auditing or must audit companies that work with medical equipment in one way or another. It can be employees who work in companies that are ISO 13485 certified, or are on the way to becoming ISO 13485 certified, or who deliver to companies that are subject to ISO 13485 requirements.
 
The course is relevant both for companies that audit ISO 13485 internally or with suppliers, and for companies that themselves are audited according to ISO 13485.
 
Course format
The course consists of 2 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 as well as the legislation regarding medical devices.
 
The entire course lasts 3 days and ends with a written multiple choice test.
 
Course language
The course is in English.
 

"A recommendable course which gives a broad understanding of ISO-13485 and the auditor role. The course has a primary focus on 13485 and the instructors were very experienced and at the same time extremely skilled at alternating between the standard's requirements and practical examples"

"Really great course, and I have already recommended it to my mgr. for my colleagues to participate"

"I liked the the knowledge the trainers had, the relevance and the accuracy of the topic’s relevance for the course"

"Competent teachers who know what they are talking about"

"I liked All of it, it really gave me the framework of our Company QMS"

Participants, Fall 2022