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Aperio Earns ISO 13485:2003 Quality Management System Certification
Validation Underscores Digital Pathology Leader's Commitment to Quality Performance
Vista, CA – August 27, 2009 – Aperio, the global leader in digital pathology for the healthcare and life sciences industry, announced today that it has earned the International Organization for Standardization's (ISO) 13485:2003 certification for the "design, manufacture, distribution and servicing of digital image analysis systems and digital slide scanning services." Aperio's certified quality management system produces its portfolio of digital slide scanners, data management and image analysis software, and services to the stringent requirements set by ISO 13485:2003.
"This certification is an independent confirmation of our dedication to and achievement of high-quality products and services that meet the needs of our national and international customers," said Dirk G. Soenksen, CEO of Aperio. "Achieving the ISO 13485:2003 certification also allows us to effectively and efficiently scale our growing business to address our customers' needs and retain our leadership position within the digital pathology marketplace."
Companies receiving the ISO 13485:2003 certification must demonstrate their ability to provide medical devices and related services that consistently meet customer and regulatory requirements. Aperio's review was performed by the BSI Group, the world's largest and most influential management systems registrar.
Globally recognized for revolutionizing digital pathology, Aperio currently has an installed base of more than 500 systems in 32 countries, including more than two-thirds of the top 15 rated U.S. hospitals, leading academic medical centers and reference laboratories, and all of the 13 largest pharmaceutical companies.
About Aperio
Aperio is the leading provider of digital pathology solutions in hospital and reference labs, academic medical centers, and biopharma institutions across the world. Today, our affordable and complete product portfolio is proven to lower costs, increase efficiencies, and enhance workflow in labs everywhere. Our comprehensive product line features our ScanScope® scanners, Spectrum™ image management (PACS) software, SecondSlide™ slide sharing service for pathology, and image analysis tools and services. Aperio's products are FDA cleared for specific clinical applications, and are intended for research and education use for other applications. For clearance updates and more information please visit www.aperio.com.
Contacts:
Jessica Witkowski
Aperio
760.539.1162
jessica@aperio.com
Myla Wagner
Myla Wagner Public Relations
925.736.7515
myla@mylawagnerpr.com