Medtech Summit Budapest 2025
February 26-27, 2025| Budapest, Hungary
We are pleased to share that we will be speaking at Medtech Summit Budapest 2025 . The conference will focus on technological innovations, regulatory trends, development resources, regulatory expectations, and best manufacturing practices.
Make sure you join our presentations and discover how our Regulatory Medtech team can help you navigate the changing regulatory landscape and design a regulatory strategy that fits your target market requirements.
About the Panel “MDR - IVDR Transition: Consultant Experiences”
Wednesday, February 26|13:30
Regulatory experts share key challenges, lessons learned, and best practices from guiding manufacturers through the Medical Device Regulation to In Vitro Diagnostic Regulation compliance. Gain practical advice on common pitfalls, timelines, and strategic adjustments for a smooth transition.
Our Speaker: Tabatha Bourgois, Director, Global Regulatory Business Development
About Our Presentation “Combination Products Under Article 117”
Thursday, February 27|14:45
Under the Medical Device Regulation, Article 117 regulates combination products, referring to medicinal products that incorporate a medical device as an integral part or are used in conjunction with a medical device. Panellist will provide an overview of the new requirements for combination products and discuss their impact from the perspective of a regulatory consultancy firm in the medtech industry.
Speaker: Sara Ramió-Pujol, Senior Regulatory Affairs Manager
Meet Our Speakers
Tabatha Bourgois
Director, Global Regulatory Business Development
Tabatha Bourgois is a regulatory and business development expert with over a decade of experience in the pharmaceutical and medtech industries. At Alira Health, she Tabatha specializes in development pathways for drug products, biologics, and medical devices, with expertise in FDA and EU regulations, including the MDR and IVDR.
With a background in materials science from EEIGM Engineering School in France, Tabatha has contributed to innovative projects in drug delivery, medical devices, and biomaterials. She is also a co-author of several patents in the medical field, reflecting her dedication to healthcare innovation.
Sara Ramió-Pujol
Senior Regulatory Affairs Manager
A seasoned expert in the development and regulatory affairs of MD/IVD products, with a focus on EMA and FDA submissions. During her career, she has played a crucial role in ensuring companies’ compliance with ISO 13485 QMS and ISO 14971 risk management standards and also made significant contributions to developing technical documentation in line with the MDR/IVDR and gained valuable experience in software development as a medical device under International Electrotechnical Commission 62304.
Discover Our Regulatory Medtech Insights
On-Demand Webinar
How can you manage the crucial differences between the EU and US regulatory landscapes and the latest updates that could impact your business? Learn what you should consider when developing your regulatory strategies and how to prioritize target markets amidst these shifting regulations.
Article
We spoke with regulatory expert Mercè Guerra to learn more about changes in the regulatory landscape in the US, the EU, the UK, and Switzerland. What should manufacturers consider when developing their regulatory strategies and prioritizing their target markets?
Checklist
This checklist can provide you with insight into where you stand in regards to MDR preparation and what you still need to address. Download now to determine your MDR preparedness.
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