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 knowledge of 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 European / International markets in its „Medical Device Regulation (MDR)“ Seminar.
„Medical Device Regulation (MDR)“-Seminar (in English)
The seminar days always take place from 8:30-12:30.
- 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 8:30 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 as a Medical Device (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)
Learn more about this seminars.
The Central Institute of Medical Engineering also offers a German seminar.
