About Us
Sapheneia is a Global imaging services company specializing in diagnostic and analytical image processing solutions since June 2006. Sapheneia is the first company dedicated to X-ray dose reduction through image quality enhancement. The engineering head quarter is at Mjärdevi SciencePark, Linköping, Sweden and the Sales- and Marketing offices are based in Stockholm, Sweden and Chicago IL, USA.
Mission
Sapheneia provides medical image optimization solutions to enable reduced dose while maintaining diagnostic confidence, to promote greater patient and medical staff safety, and improved cost-effectiveness of medical imaging.
Research and Development
Sapheneia is committed to expanding features and functionality of its existing technology product solutions and to developing new versions and new complementing technologies. Our development team has worked closely with University Hospitals and early adopters who drive aggressive change in the industry.
Regulatory Status
Sapheneia's quality management system is certified according to ISO 13485:2003 (Medical Devices - Quality Management System - Requirements for Regulatory Purposes) for the design, development and integration of software for diagnostic- and analytical medical imaging applications and sales thereof.
The Clarity Server received FDA clearance for immediate marketing and sales as a medical device in the United States in May, 2007. As of December 2007 the Clarity Server has also been CE marked for sales in Europe.
Background on ISO 13485
ISO 13485:2003 (Medical devices - Quality management systems - Requirements for regulatory purposes) is essentially ISO 9001 adapted to meet the requirements of the medical device industry and it addresses most FDA requirements (21CFR820). The main difference between ISO 9001 and ISO 13485 is that ISO 13485 is more focused towards ensuring medical device safety and efficacy rather than enhancing customer satisfaction and continual improvement.