Confinis

Confinis is a regulatory and compliance consultancy serving medical-device, in vitro diagnostic and combination-product companies. Founded in Switzerland, it works with medtech organisations across product development and commercialisation, addressing regulatory and compliance requirements in a field governed by the EU MDR, IVDR and corresponding frameworks in other markets. The firm has been part of the athagoras Group since 2025.

Its consulting work covers design control, risk management, usability engineering, clinical evaluation, auditing and the development and implementation of quality management systems, alongside medical-device cybersecurity and digital health. The firm also acts as a regulatory representative for Switzerland, the United Kingdom and the United States, giving clients a named local contact in three jurisdictions, and it serves clients worldwide from offices in those same three countries.

Training forms a distinct part of the business: the confinis Online Academy provides e-learning and professional development for the medical-device industry. For specialists in regulatory affairs, quality, clinical evaluation or human factors, the firm combines project-based consulting with structured professional education.