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Medical Devices Law and Medical Device Regulation Seminar

In order to introduce a medical device into the market it is essential not only to have the technical knowledge of the production process but also the rules and regulations of the entire product life cycle. As medical devices are products that have a medical purpose and are intended for the use of humans, manufacturers have to adhere to strict legal requirements. Consequently, knowledge of this evermore complex subject matter of medical device regulation is indispensable for any successful and competitive market entry.

The Central Institute of Medical Engineering now offers the opportunity to learn more about the regulatory requirements of medical devices for the German market (in a German seminar) and also European / International markets (in an English seminar).

Course objectives

  • The certificate courses “Medical Devices Law” and “Medical Device Regulation” offer 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

Each 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.

 

„Medical Devices Law“ – Seminar (in German)

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 network with participants as future specialists.

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

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

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.

Anmeldeformular-MPR-WiSe20-Extern
Anmeldeformular-MPR-WiSe20-Extern

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 2020/2021:

(The seminar days always take place from 8:30-12:30. Exceptions are noted at the respective session)

      • Introduction to medical device law (obligatory, 02.11.2020 & 09.11.2020 online – each from 8:30 a.m. to 12:30 p.m.)
        Christian Sauter (Siemens Healthineers), Dr. Maria Henke
      • Risk management in medical engineering (obligatory, 16.11.2020 & 23.11.2020 online – each from 8:30 a.m. to 12:30 p.m.)
        Christian Sauter (Siemens Healthineers)
      • Digital health (01.12.2020 & 08.12.2020 online – each from 8:30 a.m. to 12:30 p.m.)
        Tobias Schreiegg (Siemens Healthineers)
      • Software as a Medical Device (14.12.2020 & 21.12.2020 online – each from 8:30 a.m. to 12:30 p.m.)
        Matthias Hölzer-Klüpfel
      • Clinical Evaluation (11.01.2021 & 18.01.2021 online – each from 8:30 a.m. to 12:30 p.m.)
        Dr. Raymond Glocker (emka MEDICAL GmbH)
      • Usability Engineering (25.01.2021 & 01.02.2021 online – each from 8:30 a.m. to 12:30 p.m.)
        Michael Engler (Benkana Interfaces GmbH & Co KG)
  • Quality management systems in medical engineering (summer semester 2021)
  • Medical Device Regulation (summer semester 2021)
  • Other countries, other customs: USA, China, Brazil, Japan, Canada, Australia (summer semester 2021)
  • Medical devices on the market, in service and  application (summer semester 2021)

 

„Medical Device Regulation (MDR)“- Seminar (in English)

In this seminar you will have the opportunity to deal with the medical device regulation within the context of international matters.

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 StudOn/MDR.

RegistrationForm-MDR-WiSe20-Extern
RegistrationForm-MDR-WiSe20-Extern

MDR 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-mdr@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 2020/2021:

(The seminar days always take place from 8:30-12:30. Exceptions are noted at the respective session)

      • Introduction to the medical device law (obligatory, 04.11.2020 & 11.11.2020 online – each from 8:30 a.m. to 12:30 p.m.)
        Christian Sauter (Siemens Healthineers), Dr. Maria Henke
      • Risk management system in Medical Engineering (obligatory, 18.11.2020 & 25.11.2020 online – each from 8:30 a.m. to 12:30 p.m.)
        Christian Sauter (Siemens Healthineers)
      • Clinical Evaluation (02.12.2020 & 09.12.2020 online – each from 8:30 a.m. to 12:30 p.m.)
        Christiane Reinwald (be-on-quality)
      • Webinar (16.12.2020 online – from 11:30 a.m. to 12:30 p.m.)
        Oxford Academic Health Science Network, UK
      • Medical Products in the Market, in Operation and Application (13.01.2021 & 20.01.2021 online – each from 8:30 a.m. to 12:30 p.m.)
        Stefanie Spallek (be-on-quality), Johannes Spallek (JS IT-Consulting/IT-Solutions)
      • Software for Medical Devices (27.01.2021 & 03.02.2021 online – each from 8:30 a.m. to 12:30 p.m.)
        Matthias Hölzer-Klüpfel
  • Other countries, other customs (summer semester 2021)
  • Medical device regulation (summer semester 2021)
  • Webinar (summer semester 2021)
  • Digital Health (summer semester 2021)

 

 

Funded by:

 

Addition information