Online course: Regulatory Specialist MDR – IVDR
Your career springboard to becoming a Regulatory Affairs Manager
The next round of our online course starts on October 17, 2025: REGULATORY SPECIALIST for medical devices and in vitro diagnostics according to MDR/IVDR!
With this practical and implementation-oriented training course, we offer an overall view of all relevant topics of the MDR / IVDR in a compact online course.
Together with the other participants, you will implement the necessary knowledge and work packages step by step on the way to the successful approval of your medical device or in vitro diagnostic.
To bring medical devices and IVDs to market, the new EU regulations (MDR and IVDR) set out clear but significantly expanded requirements. If these requirements are taken into account right from the design and manufacturing stages, time-consuming and costly detours on the way to market entry can be avoided.
As a Regulatory Specialist MDR / IVDR, you can:
- conduct a professional gap analysis for MDR / IVDR and
- define the necessary work packages for implementing the MDR / IVDR”
COURSE CONTENT: Regulatory Specialist MDR & IVDR
- Module 1: Technical Documentation for Medical Devices and IVD, 17.10.2025
- Module 2: General Safety and Performance Requirements for Medical Devices and IVD, 23.10.2025
- Module 3: Requirements and Processes for the development of Medical Devices and IVD, 07.11.2025
- Module 4: ISO 14971:2019 – Risk management for Medical Devices and IVD, 21.11.2025
- Module 5: Clinical Investigation Evaluation of Medical Devices and In Vitro Diagnostics, 02.12.2025
- Module 6: Labelling and UDI Marking of Medical Devices and In Vitro Diagnostics, 26.11 + 05.12.25
- Module 7: Post-Market Surveillance (PMS), 12.12.2025
Individual modules can also be booked!
PARTICIPATION REQUIREMENTS
In order for you to benefit optimally from our online course, we recommend at least one year of prior experience in the areas of development, production, sales, quality management, market launch or approval of medical devices or in-vitro diagnostics.
Recognition of individual modules: In order to receive credit, we require confirmation of participation in a comparable seminar that has been attended in the last 3 years. If the seminar was held some time ago and you have not applied the content since then, we recommend that you attend the relevant module of this course again
Costs
- € 3.490,00 (exkl. VAT)
- Includes: Seminar documents as PDF, certificate of participation and examination fee
- Registration latest by 10.10.2025
NEW: 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.
