Litron Inc. Receives ISO 13485:2003 Certification

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Litron announces that it has received its ISO 13485:2003 certification effective October 15, 2013.

ISO 13485 Certification

ISO 13485 Certification

...a true partner in manufacturing, quality, and regulatory requirements [of medical devices]

“We’re extremely proud of achieving this goal and the hard work our staff puts in every day to ensuring we adhere to the highest quality standards. Our entire team from our quality control and quality assurance group, managers of our medical device assembly and laser services groups, to the workers processing our customer’s parts, are committed to ensuring our processes meet the strictest requirements,” says Mark Plasse, President of Litron.

“Obtaining the ISO 13485:2003 Certification confirms what we’ve known for a long time; That our quality system and our process controls are in-line with the high level of quality our customers expect and deserve,” says Brendan Fullam, Litron’s Sales & Marketing Coordinator. “Now we have the recognition to show existing and prospective clients that working with Litron is the right choice for the manufacturing of their class II and III medical devices.”

ISO 13485:2003 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 customer requirements and regulatory requirements applicable to medical devices and related services. (http://www.iso.org/iso/catalogue_detail?csnumber=36786)

"Litron's certified medical device quality management system ensures that we have the tools in place to be not just a provider of services to our customers, but a true partner in manufacturing, quality, and regulatory requirements," says Tara Douglas, Litron’s Quality Assurance Manager.

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Brendan Fullam
Litron, Inc.
+1 (413) 789-0700
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