confinis is a global consulting firm in the field of medical devices, in vitro diagnostics and combination products based in Switzerland and the USA.
Our range of services includes regulatory affairs, quality management, design control, risk management, usability engineering/human factors, clinical evaluation, labelling, manufacturing, process validation, supply chain, post-market monitoring, auditing, and training.
our competences
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.
We have mastered the theory, but we still see ourselves as practitioners who have learned from scratch.
our identity
confinis stands as the most reputable Swiss regulatory consulting firm globally, distinguished by our agile approach to regulatory challenges.
Specializing in medical devices and combination products, we expertly manage every phase from concept to commercialization, ensuring rapid market authorization for over 2,000 devices. Our services extend as the Swiss Authorized Representative (CH REP), the UK Responsible Person (UK RP) and the US Agent, demonstrating our commitment to regulatory excellence and client success.
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.
“Efficient and effective advice on medical and combination products is not rocket science — it just needs well-founded and updated knowledge as well as decades of experience!”
Beat U. Steffen, confinis founder
where to find us
With offices in Switzerland, the UK, and the USA, confinis is strategically located to best assist you with your global regulatory compliance needs.
Clients
corporate
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.
