Developing an Effective Regulatory Strategy for the Evolving 2024 Medtech Landscape

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Developing an Effective Regulatory Strategy for the Evolving 2024 Medtech Landscape

Webinar Replay

The regulatory landscape for medtech in the EU is increasingly complex, continuously evolving, and challenging to navigate. At the same time, in the US, medtech manufacturers can benefit from opportunities for assistance, such as the FDA’s Breakthrough Devices Designation and pre-submission meetings, which can result in faster approval. Companies face mounting challenges as they strive to keep up with the latest regulatory requirements in these major markets. The stakes are high: navigating these regulations effectively can mean the difference between swift market access and costly delays—or worse, exclusion from the market altogether.

In this webinar, we explored how to manage the growing regulatory demands, the crucial differences between the EU and US regulatory landscapes, and the latest updates that could impact your business. Watch the webinar to learn what you should consider when developing your regulatory strategies and how to prioritize target markets amidst these shifting regulations.

Watch This Webinar to Learn:

What are the latest regulatory updates in the EU and US?
What should you keep in mind when defining regulatory priorities?
How can you adapt a regulatory strategy for both EU and US markets?

Our Speakers

Irati Mendia Azkoaga,
Medtech Regulatory Affairs Consultant

With extensive experience in medtech regulatory affairs, Irati Mendia, PhD, has been instrumental in ensuring regulatory compliance for medical devices and in vitro diagnostic products. During her career, she has expertly navigated complex regulatory landscapes, led cross-functional teams, and collaborated with regulatory authorities to secure critical approvals.

Irati excels in developing technical files, overseeing the analytical and clinical validation of in vitro diagnostic products under the In Vitro Medical Devices Regulation (EU) 2017/746, and implementing International Organization for Standardization (ISO) 13485 quality management systems and ISO 14971 risk management protocols. Her commitment to regulatory excellence has consistently driven successful outcomes in the medtech sector.

Irati holds an industrial PhD in molecular biology and clinical research, which grounds her deep expertise and dedication to advancing medical technology.

Sara Ramió-Pujol,
Senior Regulatory Affairs Manager

Sara Ramió, PhD, is a seasoned expert in the development and regulatory affairs of medical devices and in vitro diagnostics, with a focus on European Medicines Agency and Food & Drug Administration submissions.

During her career, Sara has played a crucial role in ensuring companies’ compliance with International Organization for Standardization (ISO) 13485 quality management systems and ISO 14971 risk management standards. Sara also made significant contributions to developing technical documentation in line with the In Vitro Medical Devices Regulation (EU) 2017/746 and gained valuable experience in software as a medical device development under International Electrotechnical Commission 62304.

Before joining Alira Health, Sara served as technical manager at GoodGut SLU, where she led the Development and Design and Manufacturing departments for various in vitro devices.

Sara’s academic contributions are extensive, including numerous peer-reviewed publications and conference presentations across fields like molecular microbiology, microbial ecology, renewable resources, and digestive diseases. She has also been invited to speak at national and international conferences and has engaged in international research collaborations.

In addition to her industry experience, Sara has been an associate lecturer in the biology department at the University of Girona, where she also earned her Bachelor of Science and Master of Science in molecular biology and biomedicine, as well as a PhD with international distinction in molecular biology.