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Invitation Only
Separate Ticket or Advanced Registration Required
Separate Ticket or Advanced Registration Required
Repeat Solutions Circle
Repeat Solutions Circle

Beat U. Steffen

Founder & Chairman
confinis ag, Switzerland

With over 17 years of experience in the medical device industry, I have honed my expertise in regulatory affairs, guiding products from concept to market across diverse global landscapes. My tenure includes nearly three years as a consultant, collaborating with dynamic start-ups and established corporations to navigate the complex regulatory environment.

I have successfully developed and implemented global regulatory strategies, securing approvals from major regulatory bodies such as the FDA, EMA, and under the EU MDR for products ranging from Class I to Class IIb. My proficiency encompasses a wide array of regulatory submissions, including pre-submission discussions with the FDA, 510(k) applications, and CE marking processes.

A significant aspect of my role involves acting as the primary liaison with regulatory authorities, ensuring transparent and effective communication throughout the product lifecycle. I have a proven track record of overseeing compliance, from initial development through post-market surveillance, ensuring that all products meet stringent safety and efficacy standards.

My experience extends to the technology transfer journey from academia to industry, where I have facilitated the commercialization of innovative medical devices. By bridging the gap between research and market readiness, I have helped translate academic innovations into viable products that meet regulatory requirements and address market needs.

Collaboration with cross-functional teams is a cornerstone of my approach, integrating regulatory strategies with business objectives to enhance both financial and operational performance. I am adept at providing strategic insights that align regulatory compliance with corporate goals, ensuring that regulatory considerations are integral to decision-making processes.

In an ever-evolving regulatory landscape, I remain committed to continuous learning and adaptation, striving to facilitate the successful introduction of safe and effective medical devices to global markets.

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