BOSTON, Mass. and STOCKHOLM, Sweden – February 18, 2009 – ContextVision, a leading software imaging partner for the most recognized medical imaging manufacturers worldwide, today announced that it has gained ISO 13485:2003 certification. Globally recognized, ISO 13485:2003 standards are set by the International Organization for Standardization (ISO), the world’s largest developer and publisher of international standards. The certification, which most major OEMs require of its partners, positions ContextVision for continued work with existing customers and demonstrates to potential customers ContextVision’s ability to meet today’s industry standards.
“Our goal is to provide our customers with the very best image enhancement capabilities,” said Jan Erik Hedborg, CEO of ContextVision. “The ISO 13485:2003 certification represents our commitment to quality in 2009 as we continue to raise the bar of medical imaging enhancements and bring new products to market.”
About ISO 13485:2003
ISO 13485:2003 specifies requirements for a quality management system. To gain certification, an organization must demonstrate the ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.
ContextVision is the leading independent developer in medical imaging enhancement, analysis and processing technologies, serving leading OEMs and distributors for 25 years. ContextVision´s patented GOP algorithm allows unprecedented image quality to be achieved by simultaneously enhancing fine structure while reducing noise and speckle across MRI, X-Ray, Ultrasound and CT image data. ContextVision´s technology enables the company’s customers to provide superior digital imaging quality for hospitals and clinicians. Such solutions promise more rapid and accurate diagnoses, reduced operator eye fatigue, and ultimately, a greater return-on-investment for medical imaging users. ContextVision´s embedded imaging software is relied upon daily by thousands of users around the globe. For more information, please visit www.contextvision.com.