Online-Roundtable: Regulatory Update for Medical Software, Apps, Digital Health and AI (English)


Together with the cluster organizations Standortagentur Tirol, LISAvienna, Styria, Medizintechnik-Cluster Oberösterreich and ecoplus Niederösterreich, we are once again expanding the regional MDR regulars‘ tables into an Austria-wide online forum roundtable.

Our roundtable on May 13 will be our first one in English!

As part of this cross-cluster event, we would like to give you a regulatory update on MDR-IVDR.

This session will focus on what manufacturers need to know about Medical Device as Software under MDR with reflections on the impact of AI.


  • 16:00 Update: Life Science Cluster Austria
  • 16:15 Regulatory Update: Medical Device Software & Apps, Digital Health and Art. Intelligence
    Martin Schmid,
  • 16:40 Challenges for Medical Device Software under MDR
    Sreenath Sukumaran – Senior Technical Specialist & Scheme Manager, Active Medical Devices – BSI Regulatory Services
  • 17:20 Best Practice: Medical Software, Apps, AI under MDR
    Paul Kressnik, Business Manager – Brainhero & Health Pioneers, Verband Digitale Gesundheitsversorgung Österreich
  • 17:40 Standards for artificial intelligence in medical devices: what we have – what we need – what we can expect!
    Volker Sudmann, mdc medical device certification
  • Each presentation will be followed by an opportunity to ask the experts your specific questions!

The online forum is free of charge.

Click here to register