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We are thrilled to announce that we will sponsor, speak at, and attend MedTech World Asia 2026. This premier conference unites regulators, hospital executives, investors, corporates, and innovators defining the future of healthcare across APAC.
Make sure you join Mercè Guerra, Associate Director, Regulatory Affairs Medtech, for the panel “Beyond APAC: Building a Medtech Expansion Strategy for Europe and the USA”.
At Alira Health, our integrated model ensures that evidence generation supports not only regulatory approval, but also clinical adoption and payer decision-making across markets. Meet us onsite to learn how we can help you define claims, evidence requirements, and reimbursement pathways in parallel by aligning patient needs, regulatory, clinical, and market access strategy from the outset. Our approach will help you reduce rework and accelerate your path to commercial success both in Europe and in the US.
August 27 | 10:40 HKT
Expanding into Europe and the USA involves more than securing regulatory clearance. This panel will examine the evidence, reimbursement, pricing, adoption, and commercial strategies needed for successful market entry. Experts will also discuss regulatory expectations, quality systems, documentation requirements, and why cybersecurity should be embedded early in the expansion journey.
Mercè Guerra
Associate Director, Regulatory Affairs Medtech
Mercè Guerra leads 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.
Article
Medtech success requires more than approval. Discover how aligning evidence, patient needs, and market access drives adoption.
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
Medtech company sought support in developing a regulatory strategy for the EU launch of their product with an aggressive timeline to launch.
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