Clinius Ltd

medical devices

About

Clinical device trial and Quality Management specialist Clinius is a device CRO with focus on clinical device studies, 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 services: - Clinical device trials - Clinical evaluations - Documentation for Medical CE-marking - ISO 13485 quality management systems - Pre-audits - Training

Technologies

Route 53 Outlook Microsoft Office 365 Amazon AWS Google Analytics Nginx Google Tag Manager Mobile Friendly Render

Keywords

medical devices iso 13485 clinical trials medical device directive medical device regulation mdr ivdr clinical evaluation cer quality management medical cemark clinical device trial medical equipment manufacturing iso 14155 risk management product development healthcare equipment & supplies manufacturing clinical assessment regulatory compliance research and development in the physical engineering and life sciences regulatory affairs customized research solutions ra/qa services clinical device research medical device quality management medical device documentation services healthcare devices

Location

2 Kuortaneenkatu, Helsinki, Uusimaa, Finland, 00510

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