by Ron Shinkman | Mar 27, 2024 | Clinical Diagnostics Insider , FDA-dtet
The FDA is adding International Organization for Standardization (ISO) guidelines to its “good manufacturing” requirements
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by Glenn S. Demby | Jul 31, 2023 | CLIA-lca , Essential , Lab Compliance Advisor
Individualized quality control plans offer flexibility and the capacity to seamlessly adopt new nonwaived tests, practices, and technologies.
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by Michael A. Vera, BA , Joe M. El-Khoury, PhD, DABCC, FACB | Jan 26, 2023 | Clinical Diagnostics Insider , Diagnostic Testing and Emerging Technologies , Special Focus-dtet
Experts share new strategies for dealing with hemolysis, icterus, and lipemia interference.
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by Glenn S. Demby | Apr 7, 2022 | Articles , News , Open Content
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...
by Glenn S. Demby | Mar 17, 2022 | Articles , Clinical Diagnostics Insider , Diagnostic Testing and Emerging Technologies , FDA-dtet
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