LISAvienna Regulatory Affairs Conference 2025

15 October 2025|

1130 Vienna, Austria

Apothekertrakt, Schloss Schönbrunn: Meidlinger Tor, Grünbergstraße

Welcome to REG25!

LISAvienna cordially invites you to attend the ninth Regulatory Affairs Conference for Medical Devices and In Vitro Diagnostics, taking place on October 15, 2025, in Vienna.

Look forward to a day filled with expert presentations, interactive discussions, and practical insights into all aspects of market authorization, along with the latest updates on MDR, IVDR, and other relevant regulations. Take advantage of this opportunity to stay informed and expand your professional network.

Register now to secure your spot and join us for an unforgettable experience at a fantastic venue, Apothekertrakt, Schönbrunn Palace!

What’s new?

The conference will be conducted in English to accommodate our growing international community.
B2match, a professional partnering tool, will enhance strategic networking, especially for start-ups and newcomers.
A revised session format: 3 x 3 parallel sessions instead of 2 x 5, allowing participants to attend more discussions.
A small conference fee will be introduced to help cover rising costs (Details).

Program highlights

For additional details please check the agenda.

Keynote lecture: Smart regulatory strategies for cost-effective market entry

Maria Duguine Carrasco, an international regulatory affairs expert with over 20 years of experience, will explore actionable strategies to enter global medical device and IVD markets efficiently and affordably.
Drawing from hands-on experience navigating EU MDR/IVDR, UK, US, and other key jurisdictions, she will highlight pathways that minimize regulatory burdens without compromising compliance. The session will cover low-cost routes, leveraging special access schemes, smart geographic targeting, and practical tips for startups and SMEs aiming for fast, sustainable market entry.

Watch out for additional confirmed Speakers

3 x 3 parallel sessions: Presentations, discussions and room for your questions

Leading experts from notified bodies and and authorities will share their insights.
Peers from start-ups, SMEs, industry, consulting and academia will discuss real-world challenges and solutions.
Topics include updates on MDR, IVDR, AI Act and additional regulatory spheres, perspectives on reimbursement of digital health applications in Austria, and important topics to be considered as regards the classification of a device according to its intended use, clinical evidence, cybersecurity and post-market surveillance.

Learn more about the Agenda

Partnering supported by a professional tool

A professional matchmaking software will facilitate strategic networking, especially for start-ups and newcomers.

Learn more about B2Match Partnering and FAQs.

Exhibition and informal networking

Hand-picked exhibitors you might want to connect with.
Plenty of opportunities for informal networking.

Want to sponsor our event?

Organiser

LISAvienna - Connecting Life Sciences

About LISAvienna

LISAvienna is the cluster platform for life sciences in Vienna, which was set up at the interface of Austria Wirtschaftsservice and the Vienna Business Agency. On behalf of the Austrian Federal Ministry of Economy, Energy and Tourism and the City of Vienna, it contributes to the further development of the industry. LISAvienna supports innovative companies in the fields of biotechnology, pharmaceuticals, medical products and digital health that develop new products, services and processes in Vienna and bring them to market internationally. The platform connects these companies with development partners and lead customers. As a thought leader, LISAvienna provides a basis for decision-making to strengthen the life sciences in Vienna and helps to position Vienna as one of Europe's leading innovation centers.

Learn more

Exhibitors

Learn more about key event partners and join their info booths at REG25 in Vienna.

Visibility partners

We are delighted to have the support of outstanding partners.

This could be your organisation!

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