Module Handbook

  • Dynamischer Default-Fachbereich geändert auf EIT

Module EIT-FUN-411-M-4

Legal Framework for Handling Medical Technology (M, 3.0 LP)

Module Identification

Module Number Module Name CP (Effort)
EIT-FUN-411-M-4 Legal Framework for Handling Medical Technology 3.0 CP (90 h)

Basedata

CP, Effort 3.0 CP = 90 h
Position of the semester 1 Sem. in WiSe
Level [4] Bachelor (Specialization)
Language [DE] German
Module Manager
Lecturers
Area of study [EIT-FUN] Wireless Communication and Navigation
Reference course of study [EIT-82.781-SG#2019] B.Sc. Electrical and Computer Engineering [2019]
Livecycle-State [NORM] Active

Courses

Type/SWS Course Number Title Choice in
Module-Part
Presence-Time /
Self-Study
SL SL is
required for exa.
PL CP Sem.
2V EIT-FUN-411-K-4
Legal Framework for Handling Medical Technology
P 28 h 62 h - - PL1 3.0 WiSe
  • About [EIT-FUN-411-K-4]: Title: "Legal Framework for Handling Medical Technology"; Presence-Time: 28 h; Self-Study: 62 h

Examination achievement PL1

  • Form of examination: written exam (Klausur) (90 Min.)
  • Examination Frequency: each semester

Evaluation of grades

The grade of the module examination is also the module grade.


Contents

  • Übersicht gesetzlicher Regelungen und grundlegender Anforderungen an Medizinprodukte
  • Medizinproduktegesetz
  • Klinische Bewertung und klinische Prüfung
  • Produkthaftpflicht
  • Patentrecht in der Medizin

Competencies / intended learning achievements

  • Kenntnis der gesetzlichen Regelungen der Medizintechnik
  • Befähigung zur Bewertung medizintechnischer Geräte
  • Kenntnis in Produkthaftung und Patentrecht

Requirements for attendance (informal)

None

Requirements for attendance (formal)

None

References to Module / Module Number [EIT-FUN-411-M-4]

Course of Study Section Choice/Obligation
[EIT-82.781-SG#2019] B.Sc. Electrical and Computer Engineering [2019] Non-Technical Subjects [W] Elective Module
Module-Pool Name
[EIT-NT-MPOOL-1] Non-Technical Elective Modules