BioFinland Member

Clinical device trial and Quality Management specialist

Clinius is a device CRO with focus on clinical device studies, clinical evaluations, product documentation and quality systems according to ISO 13485. We help companies in the health and well-being sector in understanding customer needs and in meeting the official requirements for products (MDR and IVDR).

Our operations are based on a diverse and extensive team of about 10 specialists and a quick and flexible response to the changing needs and schedules of our clients. Clinius has more than 15 years of experience in the research and development of healthcare devices and software.

Our key service offering:

Clinical device trials and Clinical evaluations
Documentation for CE-marking
Quality Management Systems (ISO 13485)
Pre-audits
Quality Manager service
Market studies and Clinical training