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Medical Devices Law Seminar

Link to Teaser: Medical Devices Law Seminar on YouTube (in German)

Please click on the link above for a brief overview of our seminar.

 

The use of medical devices is subject to regulatory requirements during the entire product lifecycle. Knowledge of this ever more complex subject matter of medical device law is already indispensable during the first implementation of an idea as well as a device’s development, operation, and service.

Course objectives

  • The certificate course Medical Device Law offers a combination of knowledge acquisition in a university setting and the character of a seminar with the opportunity to make contacts with participants as future specialists.
  • You will become acquainted with the German and European legislative framework for medical technology products.
  • You will understand the conditions, connections, and interdependencies between the corresponding directives, laws, and standards.
  • You will be enabled to take the necessary measures to comply with legal requirements successfully and in a timely manner.

Course structure

This certificate course consists of 10 different seminar days with tests taken separately. Attendance at all 10 seminar topics needs to take place within two years. Following successful participation, you will receive an FAU certificate. The attendance of individual seminar days is also possible without a test. The seminar days are composed of professional lectures and practical parts, for example group work. All 10 seminar days are currently only offered in German.

Registration

Information on the dates and enrollment can be found on the registration form. The concept of this certificate course is summarized in the flyer. Students: please use the registration form for students; information on this seminar can be found under https://www.studon.fau.de/mpr.

Registration MPR WS19/20 External
Registration MPR WS19/20 External
Registration MPR WS19/20 Student
Registration MPR WS19/20 Student

MPR Flyer
Seminar information and overview

 

Information for the registration forms:
The PDF form contains the interactive field “send application (Anmeldung absenden)”. When you click on this field, it automatically opens an email program (for example, Outlook), with which you can simply send the ready-made email. If you have any problems with this, email the saved registration form manually to: zimt-mpr@fau.de. The option “I would like the documents and will pay for them (Ich möchte die Unterlagen und muss dafür bezahlen)” means that you will receive the course material printed out. These documents are always available to download from StudOn.

The seminar topics and dates for winter semester 2019/2020:

(The seminar days always take place all day from 9:00-17:00.)

  • Introduction to medical device law (06.11.2019)
    Christian Sauter, Dr. Maria Henke (Siemens Healthineers)
  • Risk management in medical engineering (13.11.2019)
    Christian Sauter (Siemens Healthineers)
  • Clinical evaluation (20.11.2019)
    Dr. Raymond Glocker (CGS Sensors GmbH)
  • Usability engineering (18.12.2019)
    Michael Engler
  • Software for medical devices (08.01.2020)
    Matthias Hölzer-Klüpfel
  • Digital health (15.01.2020)
    Tobias Schreiegg (Siemens Healthineers)

 


  • Quality management systems in medical engineering (Summer semester 2020)
  • Medical devices on the market, in operation, and in use (Summer semester 2020)
  • Other countries, other conventions: USA, China, Brazil, Japan, Canada, Australia (Summer semester 2020)
  • Medical Device Regulation (Summer semester 2020)

Addition information