OFS Specialty Photonics Division achieves ISO 13485 certification for medical sub-component manufacturing

July 27, 2009
OFS, Specialty Photonics Division, says its Avon, CT facility has achieved certification to the international management system standard ISO 13485 The facility invested in this effort because of its focus on components for the medical industry. Components manufactured in Avon--disposable and reusable probes, fibers, and assemblies--are supplied to medical device OEMs and are ultimately used in surgery and office outpatient procedures.

OFS, Specialty Photonics Division, says its Avon, CT facility has achieved 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 for quality manufacturing; the Avon facility has taken this additional step because of its focus on components for the medical industry. Components manufactured in Avon--disposable and reusable probes, optical fibers, and assemblies--are supplied to medical device OEMs and are ultimately used in surgery and office outpatient procedures.

"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.

OFS is a designer, manufacturer, and provider of optical fiber, optical fiber cable, FTTX, optical connectivity, and specialty photonics products. Its Specialty Photonics Division offers optical fiber design and modification for highly specialized and customized applications. It supplies advanced optical fibers, including specialty multimode, specialty single-mode, rare-earth doped, polarization-maintaining and other nonstandard fibers. It also manufactures specialty cables and connectors, and other specialty products, such as high-power laser components.

For more information visit the page on Specialty Photonics Division's website describing its medical market focus.

About the Author

Barbara Gefvert | Editor-in-Chief, BioOptics World (2008-2020)

Barbara G. Gefvert has been a science and technology editor and writer since 1987, and served as editor in chief on multiple publications, including Sensors magazine for nearly a decade.

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