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
Encotec, ACMIT and Metecon agreed to contribute to this session.
2 speakers
A2: Regulatory aspects around trustworthy AI
- Ali Moshayedi: Compliance and Trust Under The EU AI Act
The notified body BSI and PH - Predicting Health GmbH agreed to contribute to this session.
1 speaker
A3: Reimbursement of digital health applications across Europe
The speaker nominated by AUSTROMED, a speaker from IHS and a speaker from AI-HTA agreed to contribute to this session.
2 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
The notified body Scarlet and Gouya Insights agreed to contribute to this session. A best practice talk from an Austrian company will be announced soon.
2 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
The notified body QMD, the general hospital of Vienna and MacroArray Dx agreed to contribute to this session
2 speakers
B3: Regulatory framework in Austria, EU and US
The Austrian National Public Health Institute (GÖG) agreed to contribute to this session.
2 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
- Tina Vodopivec: 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
- Larissa Naber: The Connected Medical Device and Its Natural Enemies
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
- Daniel Rubisoier: Test Your Expertise: Classification of Devices under Regulation (EU) 2017/745 for medical devices
- Svetlana Seiter: Qualification and classification of devices under MDR and IVDR: insight into European harmonization and the national procedure in Austria
2 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.