Libra Awarded ISO 13485 Certification for Manufacture of Medical DevicesCustomers assurance of stringent control of business practices
Libra Industries, Inc. (Libra), an electronics contract manufacturer in Mentor, OH, recently received ISO 13485 certification for its medical electronics-related engineering and manufacturing operations. The certification provides Libra's customers the assurance of stringent control of business practices, electronic design services and manufacturing processes used to produce medical electronics devices as their contract manufacturer.
A focus on global or international standards is of utmost importance for manufacturers who are active in the world market. Libra has maintained ISO 9000 certification continuously since 1993 and is currently certified to ISO 9001 (2000).
ISO 13485 supplements the ISO 9001 standard with a focus on systems that are specific to the medical device industry. Some of the additional requirements of ISO 13485 relate to design controls, record retention, regulatory actions, process controls, special processes and traceability, which are considered more critical for the medical device industry.
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