Quality & Risk Management

Department

Bachelor's program Medical, Health and Sports Engineering

Course unit code

MGST-B-5-R-QR-ILV

Number of ECTS credits allocated

2.0

Name of lecturer(s)

Mode of delivery

face-to-face

Recommended optional program components

none

Recommended or required reading

- ISO 13485:2016 Medical devices — Quality management sys-tems — Requirements for regulatory purposes
- ISO 14971:2019 Medical devices — Application of risk man-agement to medical devices

Level of course unit

Bachelor

Year of study

Fall 2025

Semester when the course unit is delivered

5

Language of instruction

English

Learning outcomes of the course unit

Understand the impact of regulations on manufacturers, notified bodies, and users of medical devices.
Are familiar with risk-based approaches.

Course contents

Concept of a Quality Management (QM) System for Continuous Improvement
Responsibilities within a QM System
Definition of Quality Objectives
Content and Execution of Audits
Example-Based Risk Assessment for a Medical Device
Benefit/Risk Assessment
Handling of Corrective and Preventive Actions (CAPAs)
Incident Reporting
Post-Market Follow-Up / Vigilance System
Verification and Validation of Requirements
Calibration of Measuring Instruments

Planned learning activities and teaching methods

The course comprises an interactive mix of lectures, discussions and individual and group work.

Work placement(s)

none