EVENT | RESI Europe 2025

April 1, 2025

Today, Francisco Rodríguez participated in an engaging roundtable discussion, “Breaking Barriers: Navigating HealthTech Market Access in a Dynamic Landscape,” co-organised by Biocat, BioRegion of Catalonia.

The panel featured industry experts:

The discussion focused on the challenges and strategies for medtech innovations to successfully navigate market access.

Key Takeaways:

  • A clear regulatory roadmap is essential—not only to meet investor expectations but also to ensure a smooth market entry.

  • Strategic regulatory planning for CE marking is as crucial as developing go-to-market strategies for startups.

  • Clinical claims validation through rigorous evaluation and post-market surveillance plays a key role in product positioning within a competitive landscape.

At Asphalion, we are dedicated to supporting companies in their regulatory journey, helping them overcome challenges and successfully bring innovative healthcare solutions to market.

Need help? Contact us at: [email protected]

Let’s shape the future of HealthTech together!

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NEWS | FAQs on the European Health Data Space

The EHDS Regulation has three main parts, each with different addressees:

Chapter II on primary use provides additional rights to patients and establishes the technical infrastructure necessary for their implementation.

Chapter III on Electronic Health Record (EHR) systems is addressed to manufacturers and other economic operators who make EHR systems available on the market.

Chapter IV on secondary use is addressed to health data holders and users.

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