Presentation materials: Regulatory Update: EU AI Act, ISO 13485, ISO 14971, EUDAMED, IEC 62304, DeepTech funding, and MDR best practices from September 22, 2025
On September 22, 2025, our regular online forum, Regulatory Update, took place in collaboration with the life science clusters of all Austrian federal states.
Around 60 interested parties attended the expert updates and best practice presentations, giving them a quick, up-to-date overview of developments and requirements.
We would like to once again express our sincere thanks to all speakers and the organizing team at Human.technology Styria, LISAvienna, Standortagentur Tirol, ecoplus NÖ, Medizintechnik-Cluster OÖ, and Innovation Salzburg—without this fantastic collaboration, this free event would not have been possible!
All presentation documents are available for download here:
https://nx8775.your-storageshare.de/s/FnY8JQMYtTqpB5d
(Please copy, as we are currently experiencing technical problems!)
- Regulatory Update: EU-AI-Act, ISO 13485, ISO 14971, EUDAMED, IEC 62304
Martin Schmid, en.co.tec - Promotion meets regulation: Building bridges for deep tech innovations
Regina Weinmüllner, AWS - Best Practice: Lines of Code, Layers of Regulation – The path to the MDR-Certification
Yvonne Rauner, ESD - Best Practice: The importance of early integration of regulatory compliance – especially for Startups.
Bernhard Guggenberger und Christian Sist, Lokahi Technology Systems FlexCo
Event recommendations from Life Science Cluster & en.co.tec:
- 24.09.2025: BASG-Gespräch: Klinische Prüfungen und Leistungsstudien @ online
- 25.09.2025: HEALTH TECHNOLOGY ASSESSMENT FOR INNOVATION @ Triest
- 26.09.2025: Info-Event: en.co.tec Online-Courses @ online –
Scholarships for Start-Ups!
- 26.09.2025: Meet the experts: 1:1 Meeting @ online
- 08.10.2025: Austrian Life Science Day @ Linz
- 09.10.2025: EU-AI-Act & MDR: Webinar @ online
- 14.10.2025: Best of Biotech @ Vienna
- 15.10.2025: LISAvienna Regulatory Affairs Conference @ Vienna
Further information on the topics of QM and medical software:
- Practical guide for manufacturers of medical device software
- Quality management support & internal audits according to ISO 13485
Stay up to date:
- Regulatory Newsletter for Medical Devices and IVD
- en.co.tec on LinkedIn
- Seminars on MDR-IVDR and quality management
Would you like to deepen your knowledge?
Then we recommend our Online-Seminars, Online-Courses and the MBA-Health Tech Management.


