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)

Rubisoier Daniel, BSc MSc

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

Additional information about examination modalities

Course with final examination

Level of course unit

Bachelor

Year of study

Fall 2026

Semester when the course unit is delivered

5

Language of instruction

English

Learning outcomes of the course unit

Upon successful completion of this course, participants will be able to:

- Understand the role and importance of Quality Management Systems (QMS) in the medical device industry.
- Explain responsibilities, processes, and quality objectives within a Quality Management System.
- Understand the impact of regulatory requirements on manufacturers, notified bodies, and users of medical devices.
- Apply risk-based approaches to the assessment and management of medical device risks.
- Conduct and evaluate risk assessments and benefit-risk analyses for medical devices.
- Understand the principles, planning, and execution of internal and external audits.
- Explain the purpose and implementation of Corrective and Preventive Actions (CAPAs) as part of continuous improvement.
- Describe the requirements for incident reporting, vigilance activities, and post-market follow-up.
- Differentiate between verification and validation activities and their role in demonstrating compliance.
- Recognize the importance of calibration and control of measuring equipment in ensuring product quality and regulatory compliance.
- Apply quality management principles to support continuous improvement throughout the medical device lifecycle.s.

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