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

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