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Promega Corporation recently received ISO 13485 certification
for its Madison-based R&D and manufacturing campus. ISO 13485 is
recognized as the global quality standard for the development, manufacture, testing and delivery of medical devices.
Promega undertook the more rigorous medical device certification
as part of its commitment to enhancing its business capabilities
and expanding its product offerings into the molecular diagnostics
marketplace. Since 1998, Promega has been certified to the ISO 9001
standard.
"The ISO 13485 certification is another milestone for Promega
in supporting molecular diagnostics," says Edward Pahuski, Vice
President of Quality Assurance. "More and more molecular biology
applications are migrating into clinical and diagnostic laboratories.
It is important to Promega to create a strong infrastructure that
serves these emerging markets with the same quality that's been
delivered to life scientists for decades."
Over the past five years, Promega has supplied molecular diagnostics
markets with enzymes, components and kits. The Promega ISO 13485
certification is added assurance to existing and future laboratories
and manufacturers that Promega has established highly reliable and
effective processes for product development, manufacturing, distribution
and customer support.
About Promega
Promega Corporation is a leader in providing innovative solutions
and technical support to the life sciences industry. The company’s
1,450 products enable scientists worldwide to advance their knowledge
in genomics, proteomics, cellular analysis, molecular diagnostics
and human identification. Founded in 1978, the company is headquartered
in Madison, WI, USA with branches in twelve countries and 54 global
distributors.
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