Clinical device trial and Quality Management specialist
Clinius is a device CRO with main focus on clinical trials and ISO 13485 Quality Management consulting. We support companies in the healthcare and well-being industry in understanding the needs of customers as well as meeting the regulatory requirements (MDR and IVDR). We have more than 20 years experience with supporting device development.
Our key services
- Documentation for CE-marking
- Quality Management Systems (ISO 13485)
- MDD to MDR transformation projects
- Pre-audits
- Quality Manager service
- Clinical device trials and clinical evaluations
- Market studies
- Clinical training
