Vienna, Austria — October 2025 — Market4health attended the LISAvienna Regulatory Affairs Conference, bringing together experts from across the medical device and in-vitro diagnostics ecosystem to discuss the evolving regulatory landscape and smarter approaches to market access.
Held at Schönbrunn Palace in Vienna, the conference brought together more than 300 participants from 170+ organisations across 13 countries, with discussions spanning MDR, IVDR, trustworthy AI, reimbursement, real-world data, cybersecurity, post-market surveillance, and regulatory frameworks across Europe and the U.S.
For Market4health, the conference highlighted an increasingly important challenge for MedTech and IVD companies: regulatory strategy can no longer be separated from the broader market and evidence landscape.
Understanding how regulations evolve, what evidence is required, how payer expectations are changing, and where gaps may create risk can help teams make better decisions earlier — and avoid costly surprises later in the product lifecycle.
“What stood out to me at LISAvienna is that successful regulatory strategy is becoming increasingly data-driven. Teams need to connect regulatory requirements with evidence, market access and real-world developments much earlier in the process. AI can help make that intelligence more accessible — but only when it is built around trustworthy data, strong processes and regulatory realities.”
— Dmytro Rumiantsev, Co-founder & CPO, Market4health
The discussions reinforced Market4health’s vision of helping MedTech and IVD teams turn complex regulatory, medical and market information into actionable intelligence.
Market4health helps teams:
- Track and analyse payer and medical policy trends
- Identify evidence gaps early to reduce submission and market-access risks
- Connect European MDR/IVDR planning with U.S. market insights
- Use AI to navigate complex information and support more informed regulatory decisions
As regulatory and market-access requirements continue to evolve, Market4health is committed to building AI-powered, quality-driven solutions that help MedTech and IVD teams move from fragmented information to better, faster decisions.
We thank LISAvienna and the speakers, partners and participants for an insightful day and look forward to continuing the conversation around the future of regulatory affairs and market access.
