Our experienced and highly motivated team consists of electrical, mechanical, software, and biomedical engineers, as well as physicists, pharmacists, medical doctors, chemists, biochemists, biologists, and biotechnologists.

confinis stands as the most reputable Swiss regulatory consulting firm globally, distinguished by our agile approach to regulatory challenges.

regulatory, compliance and beyond

pro bono activities

Do you have a groundbreaking medical device or diagnostic project? At confinis, we champion innovations that transform healthcare. Navigating complex regulations is our specialty, and our pro bono program is here to help bring your ideas to life. Contact us to see how we can accelerate your project’s impact on global health. Let’s build a healthier future together.

thought leadership

At confinis, we don’t just navigate the complexities of regulatory compliance, we lead the way in thought. With extensive experience spanning global markets, our team members are recognized voices in their specialties, contributing to industry standards and advancing the conversation around critical regulatory challenges.

leveraging AI

At confinis, we harness Artificial Intelligence to enhance our regulatory solutions. AI-driven technologies facilitate advanced data analysis and process automation, speeding up compliance and providing smarter insights for medical device ventures. Discover the AI advantage with confinis.

Beat U. Steffen, confinis founder

With offices in Switzerland, the UK, and the USA, confinis is strategically located to best assist you with your global regulatory compliance needs.



Our global clients benefit from our expertise in project management, design control, clinical evaluations, human factors, and risk management. We enhance your capabilities through comprehensive training, supply chain optimization, and support in securing market authorizations, ensuring you excel in every venture.

small & mid enterprises

For start-ups and SMEs, we are more than consultants; we are partners in your growth. We build effective quality management systems and secure the necessary market authorizations. Focus on your core innovations while we handle the complexities, ensuring you can operate without distractions.

all others

At confinis, we cater to a broad range of clients, including educational institutions, research facilities, and more. Whether you’re developing cutting-edge medical technologies or improving existing products, we provide tailored solutions that ensure compliance, enhance efficiency, and drive success.