Optikos Receives ISO 13485:2016 Medical Device Certification

Sept. 10, 2020 13:04 UTC



WAKEFIELD, Mass.--(BUSINESS WIRE)-- Optikos Corporation announced today the Company has expanded its ISO certification to include ISO 13485:2016, indicating that the Optikos Quality Management System meets the most current regulatory requirements specific to the design, manufacture, and distribution of medical devices.

Optikos is a leading provider of both optical engineering and volume manufacturing services, and standard and custom products that assess and characterize image quality in lens and camera systems.

With a particular focus on developing medical devices and diagnostics enabled by optics, the Company partners with clients in life sciences hubs around the world to develop and manufacture sophisticated designs that incorporate optics and photonics, opto-mechanics, software, electronics, and automation.

“For over 20 years, Optikos has been certified to ISO 9001. Our teams work at the forefront of medical and diagnostic technologies, and this additional ISO certification is an exciting and important benchmark of Optikos engineering quality and expertise for our life sciences clients,” said Stephen D. Fantone, Optikos President and CEO. He adds, “Our product development in this area is far-reaching—from high-throughput surface plasmon resonance (HT-SPR) optical detection to disposable colonoscopes—you’ll find our work in some surprising places.”

About Optikos

The Optical Engineering Experts®--Optikos develops and manufactures standard and custom metrology products for measuring lenses, camera systems and ophthalmic components; and offers in-house IQ Lab™ testing and qualification services. Our engineering teams provide expert design and volume manufacturing for optically based product development for any application, including those in life sciences, aerospace, defense, automotive, and consumer electronics. Optikos was ranked no. 4176 on the 2020 Inc. 5000 and the Company celebrates its 38th year in business on September 9, 2020.


Susan Hess


Source: Optikos Corporation

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