Medical Device Regulation (MDR)5 ECTS
(englische Bezeichnung: Medical Device Regulation)

Lehrveranstaltungen:

• • Medical Device Regulation (WS 2021/2022)
    (Seminar, 2 SWS, Anwesenheitspflicht, Heike Leutheuser et al., https://www.zimt.fau.eu/wissenschaft/medical-device-regulation-mdr2/)
  • Medical Device Regulation (SS 2022)
    (Seminar, Anwesenheitspflicht, Lisa Walter et al., https://www.zimt.fau.eu/wissenschaft/medical-device-regulation-mdr2/)

Inhalt:

Content

In order to introduce a medical device into the market, it is essential not only to have the technical knowledge of the production process but also the rules and regulations of the entire product life cycle. As medical devices are products that have a medical purpose and are intended for the use of humans, manufacturers have to adhere to strict legal requirements. Consequently, knowledge of this evermore complex subject matter of medical device regulation is indispensable for any successful and competitive market entry. In order to receive 2.5 ECTS, you have to take part in 6 seminar days. The first two seminar days, which are offered every semester, are mandatory for students. If you prefer to join a course in the following semester, you can do so, but it is advisable to complete the seminar within one semester.

The seminar topics for the winter semester:
• Introduction to the medical device law
• Risk management in Medical Engineering
• Clinical Evaluation
• Medical Products in the Market, in Operation and Application
• Software as a Medical Product
• Introducing eMaps

The seminar topics for the summer semester:
• Introduction to the medical device law
• Risk management system in Medical Engineering
• Medical device regulation
• Digital Health
• Other countries, other customs
• Usability Engineering for Medical Devices

Lernziele und Kompetenzen:

Learning Outcomes and competencies:
The participants can explain the most important and decisive regulations in the legal framework of medical devices. They can explain the conditions, relationships and dependencies between the corresponding guidelines, laws and standards. They are able to apply the newly acquired knowledge to take timely, necessary measures to comply with the legal requirements.

Bemerkung:

This module is offered for the last time in the 5 ECTS-version for students who started it in WS 21/22. These students can finish it in SS 22 and acquire 5 ECTS credits upon successful completion.
Students who want to take MDR for the first time in SS 22, can only take the 2,5 ECTS version.

Weitere Informationen:

Verwendbarkeit des Moduls / Einpassung in den Musterstudienplan:
Das Modul ist im Kontext der folgenden Studienfächer/Vertiefungsrichtungen verwendbar:

1. Medizintechnik (Master of Science)
   (Po-Vers. 2019w | TechFak | Medizintechnik (Master of Science) | Modulgruppen M1, M2, M3, M5, M7 nach Studienrichtungen | Study Field Health and Medical Data Analytics | M1 Medical specialisation modules (HMDA) | Medical Device Regulation)

Studien-/Prüfungsleistungen:

Medical Device Regulation (Prüfungsnummer: 76451)

(englischer Titel: Medical Device Regulation)

Prüfungsleistung, Klausur, Dauer (in Minuten): 120, benotet, 5 ECTS

Anteil an der Berechnung der Modulnote: 100.0 %

Prüfungssprache: Englisch

Erstablegung: WS 2021/2022, 1. Wdh.: SS 2022

1. Prüfer:

Heike Leutheuser