Home » Education hub » MedTech World North America 2026
We are thrilled to announce that we will sponsor, speak at, and attend MedTech World North America 2026. This premier conference brings together the leaders shaping the future of the medtech ecosystem, including regulators, investors, health system and corporate decision-makers, and clinicians.
Make sure you join Mercè Guerra, Associate Director, Regulatory Affairs Medtech at Alira Health, for the panel “Unlocking US Market Access: Regulatory, Reimbursement & Your First Customers.”
At Alira Health, our integrated model ensures that evidence generation supports not only regulatory approval, but also clinical adoption and payer decision-making. Meet us onsite to learn how we can help you define claims, evidence requirements, and reimbursement pathways in parallel rather than sequentially by aligning patient needs, regulatory, clinical, and market access strategy from the outset. As a result, you will reduce rework, accelerate time to adoption, and improve the likelihood of achieving both coverage and commercial scale.
Date: May 12 | 10 AM ET
This panel will explore what it really takes to enter and grow in the US market, from navigating regulatory pathways and reimbursement strategy to securing your first commercial customers. Speakers will share practical insights on how startups can align clinical, regulatory, and go-to-market planning early to avoid costly delays and build a stronger path to adoption.
Mercè Guerra is Alira Health’s Associate Director, Regularoy Affairs Medtech, leading the development and regulatory activities for medical devices and in vitro diagnostics in the EU and US.Mercè specializes in regulatory strategy and execution across the medtech space, including CE marking, FDA clearances, and interactions such as pre-RFD, Pre-Submissions, breakthrough device designation, 513(g), and EU regulatory agency requirements. She holds a Bachelor of Science in human biology and a Master of Science in pharmaceutical and biotechnology industry from Universitat Pompeu Fabra.
Tabatha Bourgois
Director, Regulatory and Clinical Development
Case Study
The client needed an early go-to-market strategy for their IVD solution to prepare for product development and launch in key European countries and the US.
Case Study
A medtech company sought support in developing a regulatory strategy for the EU launch of their product with an aggressive timeline to launch.
Case Study
A global medtech company needed help to address FDA feedback on their implant design that included a comparator and clearly demonstrated the safety and performance of this new device.
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