Studienhandbuch | KV Equipment, plant and process safety

Inhalt

Workload	Education level	Study areas	Responsible person	Hours per week	Coordinating university
2 ECTS	M2 - Master's programme 2. year	^(*)Medical Engineering	Michael Karl Ledinegg	2 hpw	Johannes Kepler University Linz

Detailed information
Original study plan	Master's programme Medical Engineering 2022W
Objectives	Course content LVA “Geräte-, Prozess- und Anlagensicherheit“ (Michael Ledinegg) At the end of this lecture, you should be able to recognize the importance of medical devices and combination products, and know how the evolving requirements, processes and interactions when dealing with medical devices and combination products. In interactive working groups you will learn how to classify medical devices in the European Union and present the outcome during the course.
Subject	History, definition(s) and distinction of Medical Devices in relation to other products (e.g., medicinal products and cosmetics) Current Status of Devices and their Regulatory Framework Development of a medical device for the European Market Making available a medical device in Austria/European Union Life cycle management of medical devices Responsibilities of the economic operators (legal manufacturer, importers, etc) Interactive working session: Classification of medical devices in the European Union Legal bases Austrian MPG 2021 („Medizinproduktegesetz 2021”) Regulation (EU) 2017/746 and Regulation (EU) 2017/74 ISO 13485: Medical devices - Quality management systems - Requirements for regulatory purposes
Criteria for evaluation	written exam at the end of the course
Language	English
Changing subject?	No

On-site course
Maximum number of participants	-
Assignment procedure	Assignment according to sequence