Cephasonics Minnesota Manufacturing Facility Receives 13485 Certification

Blaine MN., October, 2024 -- Cephasonics, a leader in AI-enabled OEM ultrasound platforms and development systems, announced that it received ISO 13485:2016 certification for its new Blaine Minnesota manufacturing facility.  

This expands Cephasonics' ISO 13485 certification to include the manufacturing facility in Minnesota along with their San Jose technology center as of July 2024. The Minnesota received certification from American Systems Registrar that its quality management system for engineering and design as well as manufacturing have met the ISO13485 requirements.

(American Systems Registrar (ASR) is an ANAB accredited and IATF approved registrar.)
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Randall Whiting, Chief Operating Officer of Cephasonics, stated, “The receipt of the ISO certification for our new manufacturing facility continues to validate our strong commitment to quality through out device, manufacturing and customer support areas.  Notably, this ISO certification marks the continuation and acceleration of our commitment to providing best-in-class OEM platforms for developing next generation medical ultrasound systems that support our customers' requirements.”

ISO 13485:2016 an internationally recognized quality standard that is intended to ensure that medical devices and related services have consistent design, development, production, and sale of products that are fit for purpose as per intended use. To be certified, organizations must demonstrate that their Quality Management Systems are able to provide products and related services that consistently meet customer and applicable regulatory requirements.

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