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 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 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)

Further information about Medical Devices Law (Flyer, only in German)

 

The seminar topics and dates for summer semester 2021:

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

Einführung in das Medizinprodukterecht (14.04.2021 & 21.04.2021 online – each from 08:30 a.m. to 12:30 p.m.)
Christian Sauter (Siemens Healthineers), Dr. Maria Henke (Universität zu Lübeck)

Risikomanagement in der MT (12.05.2021 & 19.05.2021 online -each from 08:30 a.m. to 12:30 p.m.)
Christian Sauter (Siemens Healthineers)

Medical Device Regulation (26.05.2021 & 02.06.2021 online – each from 08:30 a.m. to 12:30 p.m.)
Stefan Bolleininger (be-on-Quality GmbH)

Qualitätsmanagementsysteme in der MT (09.06.2021 & 16.06.2021 online – each from 08:30 a.m. to 12:30 p.m.)
Dr. Holger Brünner (VisioCraft GmbH)

Medizinprodukte im Feld (23.06.2021 & 30.06.2021 online – each from 08:30 a.m. to 12:30 p.m.)
Dr. Stefanie (be-on-Quality GmbH) und Johannes Spallek (Johannes Spallek IT-Consulting/IT-Solutions)

Andere Länder, andere Sitten: USA, China, Brasilien, Japan, Kanada, Australien (07.07.2021 & 14.07.2021 online – each from 08:30 a.m. to 12:30 p.m.)
Volker Glahn (Siemens Healthineers)

Winter semester:

Digital Health (Wintersemester 2021/22)

Software für Medizinprodukte (Wintersemester 2021/22)

Klinische Bewertung (Wintersemester 2021/22)

“Usability Engineering” für Medizinprodukte (Wintersemester 2021/22)

Pricing information

8 teaching units per single seminar topic: 346,00 Euro (incl. VAT)

90 teaching units (complete course, including examination fee): 3.300,00 Euro (incl. VAT)

Discount

25% discount for members of ZiMT, ASQF e.V. and Medical Valley EMN e.V.

10% discount for members of Forum MedTech Pharma e.V.

Doctoral students: 70 Euros per course

Doctoral students enrolled at FAU receive a 50% discount.

HMDA students participate in all 10 teaching units free of charge.

Other students of the Master‘s program in medical engineering are allowed to participate in 6 teaching units free of charge. For each additional course, a fee of 35 Euros is required.

Examination

  • one time: 186,00 Euro
  • For the university certificate, all 10 seminar days must be attended within 2 years, the exams are taken separately.
  • The exam takes place on Monday 2nd August in the Bismarckstraße 1, 91054 Erlangen from 2 p.m. to 4 p.m.
    Room: Audimax, U1.060
    If your are registered, you will receive further information about the exam via e-mail.
    Contact: zimt-mdr@fau.de

Registration

Information about registration can be found in the registration form.

MPR Registration form (non-students)

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.

„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.

Further information about Medical Device Regulation (MDR)


The seminar topics and dates for summer semester 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 (28.04.2021 & 05.05.2021 online – each from 08:30 a.m. to 12:30 p.m.)
Christian Sauter (Siemens Healthineers), Dr. Maria Henke (Universität zu Lübeck)

Risk management system in Medical Engineering (26.05.2021 & 02.06.2021 online – each from 08:30 a.m. to 12:30 p.m.)
Christian Sauter (Siemens Healthineers)

Medical device regulation (09.06.2021 & 16.06.2021 online – each from 08:30 a.m. to 12:30 p.m.)
Stefan Bolleininger (be-on-Quality GmbH)

Digital Health (TUESDAY 22.06.2021 & 29.06.2021 online – each from 08:30 a.m. to 12:30 p.m.)
Tobias Schreiegg (Siemens Healthineers)

Other countries, other customs: USA, China, Brazil, Japan, Canada, Australia (07.07.2021 & 14.07.2021 online – each from 08:30 a.m. to 12:30 p.m.)
Volker Glahn (Siemens Healthineers)

Usability Engineering for Medical Devices (Block 28.07.2021 & 29.07.2021 online – each from 08:30 a.m. to 12:30 p.m.)
Michael Engler (Benkana Interfaces GmbH & Co. KG)

Winter Semester:

Clinical Evaluation (winter semester 2021)

tbd (winter semester 2021)

Medical Devices in the Field (winter semester 2021)

Software for Medical Products (winter semester 2021)

Pricing information

8 teaching units per single seminar topic: 346,00 Euro (incl. VAT)

90 teaching units (complete course, including examination fee): 3.300,00 Euro (incl. VAT)

Discount

25% discount for members of ZiMT, ASQF e.V. and Medical Valley EMN e.V.

10% discount for members of Forum MedTech Pharma e.V.

Doctoral students a fee of 70 Euros per course

Doctoral students enrolled at FAU receive a 50% discount.

HMDA students participate in all 10 teaching units free of charge.

Other students of the Master‘s program in medical engineering are allowed to participate in 6 teaching units free of charge. For each additional course, a fee of 35 Euros is required.

Examination

  • one time: 186,00 Euro
  • For the university certificate, all 10 seminar days must be attended within 2 years, the exams are taken separately.
  • The MDR Exam takes place on Monday 2nd August in the Bismarckstraße 1, 91054 Erlangen from 2 p.m. to 4 p.m.
    Room: Audimax, U1.060
    If your are registered, you will receive further information about the exam via e-mail.
    contact: zimt-mdr@fau.de

Registration

Information about registration can be found in the registration form.

MDR Registration form (non-students)

The concept of the certificate course is summarized in the flyer. This is also currently being revised and will be made available here shortly.

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.

Please visit our YouTube Playlist “Introduction to Medical Device Regulation”.