II-VI Incorporated Announces ISO 13485 Certification of Dallas Site to Design and Manufacture FDA Approved Biomedical Assemblies


PITTSBURGH, Jan. 16, 2018 (GLOBE NEWSWIRE) -- II-VI Incorporated (NASDAQ:IIVI), today announced that its product development center in Dallas, Texas has received ISO 13485 certification to support the design and manufacture of FDA approved biomedical assemblies. 

Rapid advances in life sciences are driving the growing demand for specialized equipment from certified design centers and factories. II-VI’s ISO 13485 certification at its Dallas site marks the successful implementation of a comprehensive quality management system to support the design and manufacture of medical devices and systems for FDA approved equipment.

“This certification is a part of II-VI’s strategy to leverage our thermal management and mechanical design expertise to provide FDA approved biomedical assemblies to our customers,” said Kevin MacGibbon, General Manager, II-VI Marlow.  “II-VI’s broad portfolio of materials, components and subsystems enable a wide range of biomedical equipment including PCR systems, blood analyzers, reagent chillers, as well as injury treatment and dental systems.”

II-VI provides optimum thermal management solutions for applications in life sciences, including genetic analysis, immunoassay, pharmaceutical development, clinical diagnostics, food analysis, agricultural development, environmental analysis, industrial hygiene and identification of bio-threats. II-VI’s broad array of thermal management solutions includes precision systems for thermal cycling, temperature stabilization, as well as air and fluid temperature control.

II-VI’s design lab ensures product development of the highest quality by conducting extensive performance and reliability tests, including mechanical integrity and endurance tests. II-VI’s thermal engines can include thermoelectric modules, cold plates, heat sinks, thermal interface materials, sensors and fans. II-VI also offers a broad portfolio of lasers and optics for applications in life sciences, such as for fluorescence spectroscopy and confocal microscopy.

II-VI will be exhibiting at SPIE Photonics West BiOS, Jan. 27-Feb. 1, 2018, in San Francisco, CA, Booth # 8725.

About II-VI Incorporated

II-VI Incorporated, a global leader in engineered materials and optoelectronic components, is a vertically integrated manufacturing company that develops innovative products for diversified applications in the industrial, optical communications, military, life sciences, semiconductor equipment, and consumer markets. Headquartered in Saxonburg, Pennsylvania, the Company has research and development, manufacturing, sales, service, and distribution facilities worldwide. The Company produces a wide variety of application-specific photonic and electronic materials and components, and deploys them in various forms, including integrated with advanced software to enable our customers. For more information, please visit us at www.ii-vi.com.

CONTACT:
Mark Lourie
Dir. Corporate Communications
mark.lourie@ii-vi.com
www.ii-vi.com

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/96c34c49-95ee-422e-969a-8f554ba4a579

II-VI MARLOW ISO 13485 Medical Devices

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