Vermillion's quality management system receives ISO 13485:2003 certification from BSI
Vermillion, Inc., a bio-analytical solutions company focused on gynecologic disease, has been awarded ISO 13485:2003 from the British Standards Institution (BSI), one of the world's leading certification bodies, for Vermillion's quality management system. ISO 13485:2003 certification is the internationally recognized quality standard for medical devices and diagnostics.
"Vermillion is committed to quality throughout all aspects of our business," said Valerie Palmieri, Vermillion's president & chief executive officer. "The receipt of this certification is an important achievement for Vermillion, and is a reflection of our commitment to our quality and customer experience. This is one of our building blocks for our planned International expansion."
ISO 13485: 2003 is an international standard, globally recognized for establishing quality management systems that consistently meet customer and regulatory requirements for safe and effective medical devices. ISO 13485 is based on quality management principles that have been proven to enhance organization performance. These principals relate to customer focus, management, internal processes and external relationships.
Vermillion has launched ASPiRA Labs, a CLIA certified national clinical lab, to serve as a cutting-edge biomarker diagnostics center for gynecological cancers.
Vermillion, Inc. is dedicated to the discovery, development and commercialization of novel high-value diagnostic and bio-analytical solutions that help physicians diagnose, treat and improve outcomes for patients.