Regulatory Actions
HemoSense Satisfies FDA Concerns and Completes ISO Audit
Published in Lab Law Weekly, April 27th, 2007
HemoSense, Inc. (AMEX:HEM) announced it has received acknowledgement from the U.S. Food and Drug Administration (FDA) that the Company has satisfactorily addressed the concerns about its quality management system detailed in a Warning Letter from the FDA in November 2006. The Company also announced it has successfully completed its first ISO 13485:2003 inspection audit. ISO 13485:2003 is the internationally recognized standard for medical device development and manufacturing, which the Company first achieved in 2006.
"Our commitment to maintaining world-class design, manufacturing and quality management systems to provide superior products to our customers is...
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Source: Lab Law Weekly (2007-04-27)
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