We are happy to announce that the Medical Device Regulation seminar will commence again in the summer semester 2023. Registration has already closed, but we will be opening registration for the winter semester 2023/2024 in October 2023:
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 the increasingly complex subject matter of Medical Device Regulation is indispensable for any successful and competitive market entry.
The Profile Center Medical Engineering (FAU MT) offers the opportunity to learn more about the regulatory requirements of medical devices for the European / International markets (in an English seminar) with the help of specialists from academia and industry.
Please note that the seminar “Medical Device Regulation” is taught only in English.
Contact: faumt-mdr@fau.de
Course objectives
The certificate course “Medical Device Regulation” 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 frameworks 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 topics. Attendance at all 10 seminar topics needs to take place within two years. Following successful participation, you will receive a FAU certificate. The attendance of individual seminar topics is also possible without a test. The seminar topics are composed of professional lectures and practical parts, for example, group work.
MDR Seminar topics
- Introduction to the Medical Device Regulation (SS 23)
- Risk management (SS 23)
- Clinical evaluation (SS 23)
- Software for medical devices (SS 23)
- Medical devices in the field (SS 23)
- Quality management (SS 23)
- Introduction to the Medical Device Regulation (WS 23)
- Risk management (WS 23)
- 3D-Printing in medical engineering & Artificial intelligence (WS 23)
- Other countries, other customs (WS 23)
- Usability engineering (WS 23)
- Systematic MDR-Compliant Medical Product Development (WS 23)
Timetable
02 November 2023 (kick-off in person) 8:30 – 18:00 Introduction to Medical Device Regulation 1&2
08 November 2023 (online) 8:30 – 13:00 Risk Management 1
15 November 2023 (online) 8:30 – 13:00 3D Printing in Medical Engineering
22 November 2023 (online) 8:30 – 13:00 Risk Management 2
29 November 2023 (online) 8:30 – 13:00 Other Countries, Other Customs 1
06 December 2023 (online) 8:30 – 13:00 Other Countries, Other Customs 2
13 December 2023 (online) 8:30 – 13:00 Artificial Intelligence
17 January 2024 (online) 8:30 – 13:00 Usability Engineering 1
24 January 2024 (online) 8:30 – 13:00 Usability Engineering 2
31 January 2024 (online) 8:30 – 17:30 Systematic MDR-Compliant Medical Product Development 1&2
07 February 2024 (online) Exam at 9:00 am
Pricing Information
General information:
There are 10 seminar topics for the certificate course (6 topics in one semester and 4 in the other semester).
Medical Engineering students enrolled at FAU can do one semester with 2.5 ECTS with an online exam.
Each seminar has 8 teaching units (8 x 45 minutes).
The first seminar will be an in-person event (November 2, 2023 8:30 am – 5 pm) with a networking session after the course
Pricing Information for Professionals:
- Fee per single seminar topic: 400 euros*
- Examination fee per topic: 50 euros*
- 10 seminar topics (complete course, including examination fee): 3,500 euros*
- Members of FAU MT or Medical Valley EMN e.V.: 25% Discount** for professionals only
- Members of Forum MedTech Pharma e.V.: 10% Discount** for professionals only
* Tax-free according to German law §4 Nr. 22a UStG
** Only one discount applies
Pricing Information for Doctoral Candidates:
- External doctoral candidates: 80 euros* per seminar topic.
- FAU’s doctoral candidates: 40 euros* per seminar topic.
* Tax-free according to German law §4 Nr. 22a UStG
Pricing Information for Students:
- Participation in the “Medical Device Regulation” course and the examination are free of charge for students enrolled at FAU in the degree Medical Engineering for 6 topics (1 Semester)
- For Medical Engineering Students (FAU), that want to take more than 6 Seminar Topics: 35 euros* per seminar topic
- Students of other subject-related courses enrolled at FAU: 40 euros* per seminar topic.
- External students: 80 euros*
* Tax-free according to German law §4 Nr. 22a UStG
Registration Professionals
Registration Doctoral Candidates
Registration Students
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Introduction to Medical Device Regulation on YouTube
- YouTube Playlist “Introduction to Medical Device Regulation”
- Risk Management in the medical device industry in the EU
- Quality Management Systems in the medical device industry in the EU
- Usability Engineering in the medical device industry in the EU
- Post-Market Surveillance in the medical device industry in the EU
- YouTube Playlist: “Einführung in das Medizinprodukterecht” (only in German)
- Zusammenfassung Beziehungen der Akteure (only in German)
- Zusammenfassung Gesetze und Normen (only in German)
- Überblick von der Idee zum Markt (only in German)
