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Libra Industries ISO 13485 Certified for Medical Market
January 11, 2006 |Estimated reading time: Less than a minute
MENTOR, Ohio Libra Industries received ISO 13485 certification for its medical electronics engineering and manufacturing operations. This certification gives Libra's customers the assurance of stringent control of business practices, electronic design services, and manufacturing processes used to produce medical electronics devices.
ISO 13485 supplements the ISO 9001 standard with a focus on systems specific to the medical device industry, such as design controls, record retention, regulatory actions, process controls, special processes, and traceability.