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 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 knowledge and skills, based on theoretical foundations, are rounded off with years of practical experience. As a partner, confinis offers its clients pragmatic and workable solutions.

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!

About our clients

Globally active companies



Consulting firms


Switzerland office

confinis ag, Allee 1B,
CH-6210 Sursee, Switzerland

+41 26 494 8 494

U.S. office

confinis corp., 15807 Glacier Ct,
North Potomac, MD 20878, USA

+1 240 252 0891