Plainville, CT – Gems Sensors & Controls is pleased to announce that it has achieved ISO 13485:2003 certification for it’s North American manufacturing facility located in Plainville, CT. Gems Medical Sciences a division of Gems Sensors & Controls designs and manufactures intelligent sensors, integrated subassemblies and complete fluid handling systems for OEMs in the medical and life sciences industry.
ISO 13485 is a standard specific to medical device quality systems that supplements the ISO 9001 standard. The additional requirements of ISO-13485 relate to awareness of regulatory requirements, design controls, process and environmental controls, inspection and traceability, documentation and process validation, and strong CAPA processes, all of which are critical for the medical device industry.
“ISO-13485 certification demonstrates our continued commitment to providing our Medical OEM customers service that consistently meets regulatory and quality requirements for the Medical device industry.” says Jessica Light, Gems Medical Sciences, Sales and Marketing Manager.
Gems Medical Sciences combines Gems unique array of intelligent sensors and controls with dedicated engineering expertise, world-class lean manufacturing and ISO certification. With a broad IP portfolio, decades of application engineering and proven design and manufacturing methodologies, Gems Medical Sciences is prepared to provide OEM clients with the resources and services they need to develop their next fluid handling solution.
Gems Medical Science