Event agenda
Thursday, 15 October 2026
09:00 - 10:00
Check-in
Pick up your name badge and use this time to network or visit the exhibition.
09:15 - 17:45
Exhibition
Connect with notified bodies, interest groups, service providers, and additional key partners.
09:15 - 09:55
Partnering meetings - Matchmaking - block 1
- Room 2: Sisi
- Room 4: Rudolf
- Room 7: Marie Antoinette
Meeting duration:20 minutes time slots
Arrange targeted meetings with fellow participants. Set specific meeting times, send/receive requests, and confirm appointments that align with your interests before the event. The software assigns times and table numbers for each meeting.
10:00 - 10:10
Conference opening
LISAvienna is looking forward to welcoming you at the conference.
1 speaker
10:10 - 10:40
Keynote lecture: Reinhard Krickl: Talk title tba
1 speaker
10:40 - 11:00
Regulatory Update
Between market shakeout and postponement: How the MedTech industry (should) react to the MDR/IVDR transitional periods.
1 speaker
11:05 - 12:20
A1: Turning legislation into opportunity: how to ensure a resilient, secure and competitive medtech sector
- 11:08: Petra Zoellner: Update MDR/IVDR revision
- 11:25: Wolfgang Koller: Innovation and Resilience of the MedTech Sector
- 11:45: Joachim Bogner: A company’s experience in this area and the transition to digitalisation/DiGA
- 11:53: Gregor Mandlz: DiGA-Update incl. Status and Outlook DiGA-Legislation (Act + Regulation)
- 12:00: Wrap-up with the speakers
Moderator: Michael Rupp, AUSTROMED
2 speakers
A2: EUDAMED: Insights from theory to implementation
- 11:05: Matthias Scherer: EUDAMED – Overview of Required Modules and Outlook
- 11:30: Poppy Abeto Kiesse: UDI & Device Registration: What to Do and What to Avoid
- 11:55: Ulrike Mitteregger: Our EUDAMED Journey: From „Where Do We Start?” to “We’ve Got This”
3 speakers
A3: MDR/IVDR basics and market access know-how for start-ups to increase investment readiness
- 11:05: Florian Heffeter: TBA
- 11:30: David Stadler: From Biomarker to Product: Lessons Learned from the Development of XpressGT
- 11:55: Daniela Buchmayr: Building the Path to Market: Strategic Development Planning for Start-ups
3 speakers
12:20 - 13:20
Lunch
Lunch buffet with ample informal networking opportunities.
12:35 - 13:15
Partnering meetings: Matchmaking - block 2
- Room 4: Rudolf
- Room 2: Sisi
- Room 7: Marie Antoinette
Meeting duration:20 minutes time slots
Arrange targeted meetings with fellow participants. Set specific meeting times, send/receive requests, and confirm appointments that align with your interests before the event. The software assigns times and table numbers for each meeting.
13:20 - 14:35
B1: Bridging regulation and reality: AI in medical devices under MDR and additional regulations
- 13:20: Daniela Seneca: Gaps & Practical Challenges on Medical Device Artificial Intelligence conformity assessment: Perspectives from a Notified Body
- 13:45: Dilnaz Sugralina: FDA Clearance and Maintenance of AI Medical Device Software: An EU Manufacturer’s Perspective
- 14:10: Aravinda Kumaran: Bringing AI-Powered Medical Devices to Market: Lessons from EU Technical Documentation and the Road to FDA Submission
3 speakers
B2: International market access: Strategic considerations and proven success stories
- 13:20: Martin Popovic: TBA
- 13:45: Birgit Wahlmüller & Robert Maczejka: From Quick Wins to Sustainable Growth: The MADx Success Story
- 14:10: Nina Dusper: TBA
4 speakers
B3: MDR inspections and audits: Learning from the regulator’s, notified body’s, and industry’s perspectives
- 13:20: Anja Buchberger: BASG Inspections - Structure, Process, and Common Findings
- 13:45: Thomas Schuhmacher: MDR inspections and audits: Learning from the regulator’s, notified body’s, and industry’s perspectives
- 14:10: Valentin Schwarz: TBA
3 speakers
14:35 - 15:25
Coffee break
Recharge and engage in conversation with fellow conference participants.
14:40 - 15:20
Partnering meetings: Matchmaking - block 3
- Room 4: Rudolf
- Room 2: Sisi
- Room 7: Marie Antoinette
Meeting duration:20 minutes time slots
Arrange targeted meetings with fellow participants. Set specific meeting times, send/receive requests, and confirm appointments that align with your interests before the event. The software assigns times and table numbers for each meeting.
15:25 - 16:40
C1: Regulatory workflow transformation in notified bodies and companies: How to reduce complexity and boost efficiency
- 15:25: Peter Kramar: Artificial Intelligence in Regulatory Field: Current Practice, Challenges, and Future Directions
- 15:50: Batoul Belal: From Self-Certification to Notified Body Approval: Lessons from nyra health’s Class I MDD to Class IIa MDR Journey
- 16:15: Lukas Poterpin: Industry insights: Why manufacturers automate now, how they get started, and the impact on regulatory teams
3 speakers
C2: IVDR: Regulatory deep dive, practical insights and key considerations for in-house IVD
- 15:25: Elisabeth Jaeckle & Harald Guldan: Borderline cases: When classification gets tricky
- 15:50: Andreas Oberleitner: The "Everyday Exemption”: In-House IVDs under the IVDR
- 16:15: Simone Sturm-Emerstorfer & Lukas Katacic: Navigating Class D IVDR Certification – Best Practices
5 speakers
C3: Experts’ Corner: Deep dives across R&D, clinical trials, and NIS2 compliance
- 15:25: Ghazaleh Gouya Lechner: Start Early, Plan Smart Building: Building a Sound Clinical Strategy for Medical Devices
- 15:50: Barbara Kapeller, Manfred Bammer & Thomas Schneider: Preclinical Research, Training and Usability Services
- 16:15: Nilaykumar Patel: Cybersecurity: ISO 27001, NIS2 and Cyber Resilience Act – Status Quo
5 speakers
16:40 - 18:00
16:45 - 17:45
Partnering meetings: Matchmaking - block 4
- Room 4: Rudolf
- Room 2: Sisi
- Room 7: Marie Antoinette
Meeting duration:20 minutes time slots
Arrange targeted meetings with fellow participants. Set specific meeting times, send/receive requests, and confirm appointments that align with your interests before the event. The software assigns times and table numbers for each meeting.