You can start with any module at any time and complete the remaining modules in one of our next runs!
Course language: ENGLISH
COURSE CONTENT: Regulatory Specialist EU-MDR & IVDR
| Modul 1 | Technical Documentation for Medical Devices and IVD | 02.10.2026 |
| Modul 2 | General Safety- and Performance Requirements for Medical Devices and IVD | 09.10.2026 |
| Modul 3 | Requirements & processes for the development of medical devices & IVDs | 21.10.2026 |
| Modul 4 | ISO 14971:2019 – Risk management for medical devices & IVDs | 06.11.2026 |
| Modul 5 | Clinical testing & evaluation of medical devices and in-vitro diagnostics | 20.11.2026 |
| Modul 6 | Labeling and UDI marking of medical devices and in-vitro diagnostics | 26.11. + 04.12.2026 |
| Modul 7 | Post Market Surveillance (PMS) | 10.12.2026 |
| Optional | Person responsible for regulatory compliance (not included in the course price!) | 07.10.2026 |
Individual modules can also be booked!
PARTICIPATION REQUIREMENTS
In order for you to benefit optimally from our online course, we recommend prior experience in the areas of development, production, sales, quality management, market launch or approval of medical devices or in-vitro diagnostics.
Costs
- Early bird fee (until 04.09.2026): € 3.150,- (exkl. USt.)
- Standard fee: € 3.490,00 (excl. VAT)
- Includes: Seminar documents as PDF, certificate of participation and examination fee
- You can start with any module at any time and complete the remaining modules in one of our next courses!
! en.co.tec scholarship 2 x 490,- apply now!
Discounts
Get 10 % discount for:
- Cluster members (Standortagentur Tirol, Forum Medtech Pharma, Human.technology Styria, LISAvienna, MTC Oberösterreich, Innovation Salzburg, ecoplus NÖ),
- from the 2nd participant of a company / organization,
- for repeat visitors who have already attended en.co.tec seminars.
- The discounts cannot be combined
- All seminar discounts at a glance
VENUE: ONLINE
All you need for our ONLINE courses is a laptop with a camera and microphone. Our eLearning platform works on all operating systems in a web browser.
You will receive the seminar documents and the link to the virtual seminar room by email in good time. The seminar will be interactive – similar to a face-to-face seminar: i.e. you can ask the lecturer your questions, there will be exercises and also the opportunity to exchange ideas with the other participants.