Our Certifications & Licenses
ISO 13485:2016 / ISO 11135 | MD 570749
Fully certified, consistent, quality sterilization service.
BSI, our Notified Body, was selected for the rigor they bring to the certification process and the consistency of their performance. In addition, certification by an EU Notified Body means that products intended for use in the EU can be sterilized at Blue Line knowing that their Notified Body will not require additional third-party audits.
Blue Line completed its first ISO 13485 certification audit in March, 2011. BSI has found no nonconformities, verifying what our customers already know: that we provide consistent, controlled, quality EO sterilization services. View a copy of the ISO certificate.
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Blue Line has been inspected by the California Food & Drug Branch of the Department of Public Health and issued a license to manufacture medical devices.
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Blue Line has been inspected by the USFDA and is a registered contract sterilization service.
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Blue Line is a contract sterilization company based in Novato, CA and the only provider in the market specializing only on EO/EtO processing.
Call us at (415) 884-2935 if you have questions or would like more information.