Course: medical product legislation

Course no. :n/a
ECTS credits:2.5
Lecturer(s):Prof. Dr. E. Schmittendorf
Available: winter term summer term
Course type:Lecture/practical exercises
Exam type:Written e. 1h or oral examine
Exam requirements: 
Objectives:The student understands the essential rules of medical device legislation and is able to participate in their application.
Course contents:European medical device directive (MDD), German medical device act (MPG), risk analysis, application of harmonized standards, conformity assessment procedures, quality management for manufacturers of medical devices.
Literature:Leitgeb: Safety of Electromedical Devices (Springer 2010), Medizinprodukte-Richtlinie (93/42/EWG), Medizinproduktegesetz (MPG).
available in modul:medical engineering safety and medical product legislation in semester 6
specialization area medical technology (50ECTS) in semester 6