CUPERTINO, Calif.–(BUSINESS WIRE)–BioImagene today announced that it has received the prestigious ISO 13485:2003 certification from Intertek Testing Services.
The ISO 13485:2003 is an internationally recognized Medical Device Quality Management System (QMS) standard. The standard provides requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
Dr Joe Keegan, BioImagene board member commented, “The prestigious ISO 13485:2003 certification is a significant milestone for BioImagene. It demonstrates BioImagene’s commitment to global quality standards with products built under recognized quality processes. It increases customer confidence in the products that we deliver and our value to the medical device community.”
Dr. Dave Baunoch, President, ClinPath Advisors said, “The ISO certification demonstrates that BioImagene is firmly committed to continuous quality improvements of business operations to meet their customers’ needs. In the highly competitive clinical market, BioImagene ISO Certification demonstrates their strong commitment to be the leader in automated imaging solutions.”
Mohan Uttarwar, CEO BioImagene said, “We are delighted to receive the ISO 13485:2003 certification. We believe we are the first digital pathology company manufacturing whole slide scanners to receive it. It affirms to the medical community that at BioImagene, the requisite quality systems are in place and these systems are consistently executed in daily operations. This certification will help us accelerate the system design and development and ultimately improve product quality for current and prospective customers.”
BioImagene was granted this certification after rigorous audits, extensive document reviews and auditee interviews. This certification reinforces to customers that BioImagene operates its Medical Device QMS in accordance with the globally recognized standard.
About Intertek Testing Services, NA Inc.
Intertek operates a global network of more than 1,000 laboratories and offices and over 21,000 people in 110 countries around the world. The history of Intertek spans 122 years and evolves from the combined growth of 15 innovative companies.
BioImagene is a leading provider of total digital pathology solutions for applications including clinical diagnostics and drug discovery. BioImagene products are FDA cleared for specific clinical applications, and are intended for research use for other applications.