Williamsburg VA — LEONI Fiber Optics Inc. (formerly RoMack) has hired Oxebridge to expand its current ISO 9001:2008 system to include the medical device manufacturing standard ISO 13485. Oxebridge has begun this effort in the past few weeks, and the project is expected to be completed in about one month, using a Rapid ISO 13485 Upgrade Program.
LEONI’s Virginia facility fabricates fiber optic devices, and has expanded into the medical device industry, with laser light products used for surgical applications. The work done by Oxebridge will include implementation of ISO 13485 as well as specific requirements under the FDA regulations codified in US 21CFR Part 820 and the Canadian Medical Device Regulations (CMDR). Work by Oxebridge is also being done to make it easier for LEONI to submit the devices for medical device CE Marking later on, if desired.
Oxebridge had implemented RoMack’s ISO 9001 system in 2006 under its Rapid ISO 9001 Implementation Program.
For more on LEONI Fiber Optics, visit the company’s site at www.leonifo.com.
For more on Oxebridge’s ISO 13485 medical device quality management system implementation program, click here.
Christopher Paris is the founder and VP Operations of Oxebridge. He has over 35 years’ experience implementing ISO 9001 and AS9100 systems, and helps establish certification and accreditation bodies with the ISO 17000 series. He is a vocal advocate for the development and use of standards from the point of view of actual users. He is the writer and artist of THE AUDITOR comic strip, and is currently writing the DR. CUBA pulp novel series. Visit www.drcuba.world
