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Established Medical Sub-Component Manufacturer Achieves ISO 13485 Certification
Date:7/28/2009

AVON, Conn., July 28 /PRNewswire/ -- OFS, Specialty Photonics Division, today announces its Avon facility's certification to the international management system standard ISO 13485, as verified by Bureau Veritas Certification. All OFS Specialty Photonics Division facilities have maintained ISO 9001 certification to help ensure the quality and repeatability of its product manufacturing. The Avon facility has taken the additional step to acquire ISO 13485 because of its strong focus on component manufacturing for the medical industry. Medical components manufactured in Avon include both disposable and reusable probes, fibers, and assemblies supplied to OEMs in the medical device industry and used in surgery and office outpatient procedures.

(Photo: http://www.newscom.com/cgi-bin/prnh/20090728/CL53025 )

"We maintain very close relationships with our customers, and found that they would find it much easier to do business with us if we had the additional (ISO 13485) certification. So we made the business decision to implement the systems, documentation, and auditing processes necessary to help ensure the level of quality our customers required," said Mike Winslow, Quality Manager for OFS, Specialty Photonics Division.

"More and more, medical device manufacturers are asking their suppliers to be 13485 certified. Being certified allows us to further satisfy our key medical customers and create new opportunities," added Steve Allen, OFS's Medical Market Manager. Mr. Allen went on to say, ". . .with 25 years of experience designing and manufacturing optical fibers and fiber based products, medical OEMS can rely on us to meet their customers' critical specifications and help get to market faster."


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