Williamsburg VA — LEONI Fiber Optics, Inc. has been recommended for ISO 13485 certification by NSF-ISR, pending review paperwork by the registrar’s certification committee.
LEONI had formerly undergone Rapid ISO 9001 Implementation by Oxebridge when the company was known as RoMack, and recently upgraded its system to the medical device standard ISO 13485 in order to begin selling a new fiber optic device targeted for surgical use.
Oxebridge utilized a Rapid ISO 13485 Upgrade Program, spending only two weeks at LEONI in order to upgrade their manufacturing methods and QMS to meet the requirements of the new standard.
For more on LEONI Fiber Optics, visit www.leonifo.com
For more on Oxebridge’s ISO 13485 programs, 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
