TAG:
quality assurance system
ISO 15189 Gains Favor For Lab Accreditation
CEO SUMMARY: Volunteers for the Clinical and Laboratory Standards Institute (CLSI) are in the midst of anĀ 18-monthĀ project to help fiveĀ …
FDA Sends Warning Letter to Abbott Laboratories
CEO SUMMARY: On March 13, 2007, the Food and Drug Administration sent a warning letter to Abbott Laboratoriesā Chairman and CEO, Miles D. White. The letter identified nine quality system violations and requested a satisfactory response by August 15, 2007. The warning letter is based on …
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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