BEVERLY, MA--(Marketwire - March 17, 2009) - Enzymatics, specialists in the development,
manufacture, and distribution of analytical grade molecular biology enzymes
for the research and diagnostic markets, has been awarded certification to
the ISO 13485:2003 and 9001:2000 standards by certification body TUV SUD
America.
Enzymatics is focused on the development, production, and support of
proteins for use in nucleic acid detection technologies, and was founded in
2006 by industry-veterans Stephen Picone and Christopher Benoit. "Our
mission is to efficiently scale the manufacture of analytical-grade
catalytic proteins to meet the needs of the industrial user. We focus on
the clinical diagnostic and research markets, so it is imperative that we
are able to consistently meet the needs of our customer base for both
product quality and regulatory compliance," states Mr. Benoit, the
company's Chief Operating Officer and architect of the company's quality
system. "Additionally, TUV cited Enzymatics' manufacturing process as a
best practice. We selected TUV based on their reputation in our industry,
and the fact that our manufacturing workflow stood out from our well
respected peers underscores our efforts to redefine the way proteins are
produced and delivered to the marketplace."
Stephen Picone, Enzymatics President, stated: "We are pleased with both
the speed and efficiency of our ISO 9001:2000 and 13485:2003
implementation, and the fact that we were awarded the certifications on our
first attempt. Enzymatics was built upon its reputation for providing the
highest quality products and services available in the marketplace, and
these independent certifications demonstrate that our commitment to quality
spans the entire organization. We continue to build a value added business
and our level of compliance ensures efficient integration into our
customers' sophisticated supply chains."
ISO 13485:2003 is a globally recognized standard that specifies
requirements for a quality management system where an organization needs to
demonstrate its ability to provide medical devices and related services
that consistently meet applicable customer and regulatory requirements. The
primary objective of ISO 13485:2003 is to facilitate harmonized medical
device regulatory requirements for quality management systems. The ISO
9001:2000 standard shares significant overlap with 13485:2003 while
including a focus on continuous improvement and customer satisfaction.
Enzymatics Quality Management System encompasses the design, development,
production, contract manufacture and distribution of molecular biology
enzymes.
About Enzymatics
Enzymatics is unlocking the potential of consumer genomics by delivering
high value molecular biology enzymes to drive cutting edge nucleic acid
detection technologies. The Company's technical team continually applies
its world-class skill in the development of biologics to produce a growing
suite of enzymes manufactured to meet analytical specifications compliant
to the ISO 13485:2003 and 9001:2000 standards. The company is privately
held and Enzymatics products and services are available worldwide directly
through the Beverly, MA office. Please visit www.enzymatics.com for more
information on the company, products, and business strategy.