Hooper Holmes (NYSE Amex:HH) today announced that its Heritage Labs division received a Certificate of Registration on May 28, 2010 and is now an ISO 13485:2003 registered company.
“We are among 15,000 organizations across 88 countries and economies that have been awarded the ISO 13485 certification”
The certification for ISO 13485:2003 means that Heritage Labs has passed all of the audit requirements and is officially recognized as being a provider of medical devices and related services that consistently meet customer and regulatory requirements.
The certification also means that Heritage Labs has developed, implemented, and maintained a quality management system that focuses on providing safe and effective medical devices. ISO 13485 is currently recognized by the European Union, the United States, Canada, Japan, and Taiwan, among others.
"The award of this certification officially recognizes Heritage Labs as committed to quality and providing high-level customer service," said Lori E. Gorman, Chief Operating Officer of Heritage Labs, Hooper Holmes Health & Wellness and Hooper Holmes Services.
"We are among 15,000 organizations across 88 countries and economies that have been awarded the ISO 13485 certification," added Mark Patterson, President of Heritage Labs,
Heritage Labs has attained several other highly coveted certifications and registrations including:
- College of American Pathologists (CAP) accreditation
- Clinical Laboratory Improvement Amendments (CLIA) license
- FDA approval as a medical device manufacturer
- National Glycohemoglobin Standardization Program (NGSP) certification for hemoglobin A1c testing
- SAS 70 certification for improved data center security processes
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