Sapheneia is a Medtech software company specializing in diagnostic and analytical image processing solutions. Sapheneia has been in operations since 2006, delivering products that enables radiation dose reduction through image quality enhancement. Sapheneia has offices in the USA and in Sweden, with development engineering focused at the Mjärdevi Science Park in Linköping, Sweden.
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.
Sapheneia's quality management system is certified according to ISO 13485:2012 (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 13485:2012 (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.