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CLSI AUTO11-Ed3
Information Technology Security of In Vitro Diagnostic Instruments and Software Systems - 3rd Edition
This practical guide, compiled with the help of experts from the in vitro diagnostics industry, is intended for the laboratory that is creating laboratory developed tests that may be subject to the US Food and Drug Administration (FDA) regulations, specifically the Quality System Regulation (QSReg), 21 CFR Part 820.
Clinical And Laboratory Standards Institute [clsi]