Careside Validates Manufacturing System

Following an independent review of the quality management system for the Careside Analyzer, Careside, Inc. (Culver City, CA, USA) has announced that the system meets ISO 9001 standards and is compliant with U.S. Food and Drug Administration (FDA) requirements. The review was made by Arthur D. Little (ADL), a global management and technology consulting firm.

ADL was retained to review design details of the various technology components of the Analyzer as well as the manufacturing process used by the contract manufacturer. This review resulted in the implementation of design improvements in the manufacturing process of the Analyzer. The review did not include the manufacturing process or product design of the system's test cartridges.

Careside's Analyzer provides an efficient means of measuring blood chemistry, electrochemistry, and coagulation function at the patient's point of care by producing test results within 15 minutes. "While we experienced initial problems common in the manufacturing of complex medical devices, the current manufacturing process is meeting our expectation and consistently producing high-quality and reliable instruments,” said Vickery Stoughton, chairman and CEO of Careside.



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