Medical Technology Management (MTE210)

Content

Introduction to laws, regulations and norms within medical technology management with a focus on equipment, risk analysis, patient safety, ethics, and responsibilities.

Learning outcome

• Understand roles and responsibilities within the biomedical engineering department - and how engineers tackle challenges concerning medical equipment, such as hospital duties, risk analysis, and quality assessments.

• Identify technology risks associated with medical equipment and patient-related safety such as electrical-, radiation-, mechanical safety, patient data management, and cybersecurity.

• Identify obligations and recommendations related to ethics, responsibilities, and hygiene.

• Identify regulations related to artificial intelligence (AI)-based medical devices , e.g., EU AI Act and AI law.

• Gain insights into the safety and management aspects of imaging equipment based on X-rays, radioactive radiation, and non-radiation modalities. This includes imaging modalities such as computed tomography (CT), positron emission tomography (PET), and magnetic resonance imaging (MRI).

Required prerequisite knowledge

Exam

Coursework requirements

4 theoretical assignments must be approved within the specified deadlines to be allowed to take the final exam.

Course teacher(s)

Course coordinator:

Coordinator laboratory exercises:

Study Program Director:

Coordinator laboratory exercises:

Head of Department:

Method of work

4 hours lectures and 4 hours problem solving per week.

Open for

Open course for all students with an active right to study and who meet the requirements for general university admissions certification (GSK).

Course assessment

Literature