Safety

Studiengang
  • Master's program Medical Technologies
Kennzahl der Lehrveranstaltung
  • MSE-M-3-ILV-REG
Niveau der Lehrveranstaltung laut Lehrplan
  • Master
Semester in dem die Lehrveranstaltung angeboten wird
  • 3
Anzahl der zugewiesenen ECTS-Credits
  • 5.0
Name des/der Vortragenden
  • Dipl.Ing.(FH) Goldbach Günter
Lernergebnisse der Lehrveranstaltung
  • Students
    • Know and understand the key points on relevant standards for medical product development, certification, marketing and market surveillance
    • ISO 9001 Quality Management
    • DIN 58298 Medical Instruments
    • ISO 22870 Point of Care diagnostics POCT
    • ISO 23640 In-vitro-Diagnostics
    • Are familiar with good clinical practice GCP
    • Are able to design a CRF case report form
Art der Veranstaltung
  • face-to-face
Voraussetzungen laut Lehrplan
  • none
Lehrinhalte
  • - Software as a medical product
    - Medical device Vigilance
    - Risk Management on medical products ISO 14971
    - Electrical safety, legal base and inspection
    - Sterile products legal base and inspection
    - Inspection on medical devices
    - CAPA Corrective And Preventive Action Processes
    - Shelf time and Live cycle of medical products and in-vitro-Diagnostics
empfohlene Fachliteratur
  • - Standards:
    o ISO 13485 Medical Devices
    o ISO 9001 Quality Management
    o ISO 14971 Medical Devices Risk Management
    o IEC 60601 / 80601 Electrical Medical Devices
    o DIN 58298 Medical Instruments
    o ISO 22870 Point of Care diagnostics POCT
    o ISO 23640 In-vitro-Diagnostics
    o ISO 14155 Clinical Trials on Medical Products
    o GCP-ICH
    - M. H. Cohen, Future medicine: Ethical dilemmas, regulatory challenges, and therapeutic pathways to health care and healing in human transformation. Ann Arbor: University of Michigan Press, 2003.
    - J. I. Gallin and F. P. Ognibene, Eds., Principles and practice of clinical research, 4th ed. London: Academic Press, 2017.
    - S. Gopalaswamy and V. Gopalaswamy, Combination products: Regulatory challenges and successful product development. Boca Raton: CRC Press, 2008.
    - Institute of Medicine, Medical devices and the public's health: The FDA 510(k) clearance process at 35 years. Washington: National Academy Press, 2011.
    - H. F. Lynch and I. G. Cohen, Eds., FDA in the twenty-first century: The challenges of regulating drugs and new technologies. New York: Columbia University Press, 2015.
    - L. M. McNamee, M. J. Walsh, and F. D. Ledley, "Timelines of translational science: From technology initiation to FDA approval," PloS one, vol. 12, no. 5, 1-13, 2017.
    - OECD Publishing, "Regulatory Frameworks for Nanotechnology in Foods and Medical Products: Summary results of a survey activity," Paris, OECD Science, Technology and Industry Policy Papers No. 4, 2013.
    - J. E. Riviere and G. J. Buckley, Eds., Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, 2012.
    - E. Waldman, "Strangers in the Night: Law and Medicine in the Managed Care Era," Journal of Health Politics, Policy and Law, vol. 29, no. 6, pp. 1241-1248, 2004.
Lehr- und Lernformen
  • The course comprises an interactive mix of lectures, discussions and individual and group work.
Prüfungsmethode
  • To monitor the students’ learning this course will provide ongoing assignments as a basis for feedback and grading (formative assessment) and/or will evaluate the students learning at the end of the course or an instructional unit via exams, final project reports, essays or seminar papers (summative assessment).
Unterrichtssprache
  • English