Course contents *
The course is organized under five headings:
Organization of clinical engineering
We discuss the handling of medical devices in hospitals, the organization of the county council, quality assessment/development in medical care, and medical device companies.
Regulations and responsibilities
We examine the regulatory framework for medical devices and how authorities and organizations are working with medical devices. Risk analysis, accidents, and responsibility are also addressed here.
Technical safety and standardization
This part concerns the use of standards, medical device construction requirements and documentation, and also EU harmonization of standards.
Public purchasing of medical devices
We learn how to work with the Public Procurement Act and other demands from the EU.
Maintenance of medical devices
We learn basic maintenance and management of medical equipment.
Teaching activities: Lectures, laboratory lessons, study visits, demonstrations, and project work.