CLIA QMS and ISO Risk Management Standards Recognized by FDA
The US Food and Drug Administration (FDA) has now recognized the 5th edition of CLSI's Quality Management System Model for Laboratory Services (CLSI QMS01, 5th ed. June 2019) which replaces the previous QMS01-A4. You can find the latest version here.
International Organization for Standardization (ISO) risk management standard for medical devices, ISO 14971:2019 has also been revised. The Latest version ISO 14971:2019 can be browsed here.
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