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[ 554SIMMDREU24 ] KV Medical Device Regulation(s) in the European Union, US and ROW
Versionsauswahl
Workload Education level Study areas Responsible person Hours per week Coordinating university
2 ECTS M1 - Master's programme 1. year (*)Medical Engineering Michael Karl Ledinegg 2 hpw Johannes Kepler University Linz
Detailed information
Original study plan Master's programme Medical Engineering 2024W
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
Earlier variants They also cover the requirements of the curriculum (from - to)
554SIMTGAPK22: KV Equipment, plant and process safety (2022W-2024S)
On-site course
Maximum number of participants -
Assignment procedure Assignment according to sequence