Using the IQCP Process to Improve CLIA Compliance and Lab Testing System Quality
Individualized quality control plans offer flexibility and the capacity to seamlessly adopt new nonwaived tests, practices, and technologies.
How to Resolve Three Common Types of Preanalytical Interference
Experts share new strategies for dealing with hemolysis, icterus, and lipemia interference.
Device Makers to FDA: Give Us More Time for ISO 13485 Harmonization
On Feb. 23, the U.S. Food and Drug Administration (FDA) issued a proposed rule to harmonize its good manufacturing practices (CGMP) regulations for medical devices with International Standardization Organization (ISO) 13485. The basic proposal is to replace the...
One Year Is Not Enough to Harmonize Quality Systems with ISO 13485
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