Event agenda
Wednesday, 15 October 2025
09:00 - 10:00
Check-in
Pick up your name badge and use this time to network or visit the exhibition.
09:20 - 10:00
Partnering meetings - Matchmaking - block 1
- Room 2: Sisi
- Room 4: Rudolf
Meeting duration:20 minute 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
10:00 - 17:00
Exhibition
Connect with notified bodies, interest groups, service providers, and additional key partners.
10:10 - 10:40
Keynote lecture: Smart regulatory strategies for cost-effective market entry
Low-cost routes, leveraging special access schemes, smart geographic targeting, and practical tips for startups and SMEs aiming for fast, sustainable market entry
1 speaker
10:40 - 11:00
MDR and IVDR Update
Between market shakeout and postponement: How the MedTech industry (should) react to the MDR/IVDR transitional periods.
1 speaker
11:00 - 12:15
A1: Softwaretools for supporting regulatory affairs
Moderator: Martin Schmid
5 speakers
A2: Regulatory aspects around trustworthy AI
- Ali Moshayedi: Compliance and Trust Under The EU AI Act
- Diether Kramer: Mind the Risk: Bringing Clinical Risk Prediction into Compliance.
2 speakers
A3: Reimbursement of digital health applications across Europe
Moderator: Philipp Lindinger
4 speakers
12:15 - 13:15
Lunch
Lunch buffet with ample informal networking opportunities.
12:15 - 13:15
Partnering meetings: Matchmaking - block 2
- Room 4: Rudolf
- Room 2: Sisi
Meeting duration:20 minute 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.
13:15 - 14:30
B1: Leverage real-world data for your clinical development
- Ghazaleh Gouya: Real-world data – how to use them for generating clinical evidence pre- and post market
- Camille Petri: The Notified Body’s Perspective on Using Real-World Evidence for Clinical Evaluation of Medical Device Software
- Katarzyna Malenczyk: Driving Clinical Development with RWD: Lessons from mySugr's PMCF Plan
3 speakers
B2: Session on regulatory aspects around IVDs
- Ingrid Blaimaumer: Manufacturers & Notified Bodies: Overcoming IVD Certification Hurdles
- Christian Schweiger: Best practice on in-house IVDs: process and examples
- Birgit Wahlmüller: IVDR in Practice: Challenges of Sampling, Changing Reviewers and Lessons Learned
3 speakers
B3: From theory to reality: practical approaches and regulatory framework in EU and US
- Friederike Windisch and Nina Zimmermann: Transition to MDR/IVDR: status quo of economic operators
- Monika Hupfauf and Martin Popovic: Regulatory Fork in the Road: US or EU First? Pros and Cons
4 speakers
14:30 - 15:15
Coffee break
Recharge and engage in conversation with fellow conference participants.
14:30 - 15:15
Partnering meetings: Matchmaking - block 3
- Room 4: Rudolf
- Room 2: Sisi
Meeting duration:20 minute 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.
15:15 - 16:30
C1: Cybersecurity and IT security
- Larissa Naber: The Connected Medical Device and Its Natural Enemies
- Aljaz Podborsek: Cybersecurity of Software in Healthcare and Medical Devices - the Role of the IEC 81001-5-1 Standard
- Nilaykumar Patel: Cybersecurity for SaMD: Cybersecurity-related Documentation in Technical File Preparation for Review by Notified Body
3 speakers
C2: Post market surveillance and periodic safety update report (PSUR)
- Volker Sudmann: Looking beyond the horizon – what matters regarding PSUR
- Viktoria Knoflach: Post-Market Surveillance requirements and submission of PSURs for class III / Implantable devices
- Birgit Sebauer: PMS and its requirements in countries beyond Europe
3 speakers
C3: Classification of medical devices
- Svetlana Seiter: Qualification and classification of devices under MDR and IVDR: insight into European harmonization and the national procedure in Austria
- Daniel Rubisoier: Test Your Expertise: Classification of Devices under Regulation (EU) 2017/745 for medical devices
Moderator: Martin Schmid
3 speakers
16:30 - 18:00
16:30 - 17:40
Partnering meetings: Matchmaking - block 4
- Room 4: Rudolf
- Room 2: Sisi
Meeting duration:20 minute 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.