AssurX provides comprehensive solutions for compliance with 21 CFR 820, ensuring medical device manufacturers meet FDA’s Quality System Regulation requirements. Our platform enhances quality processes, streamlines documentation, and supports operational excellence to maintain compliance.
The U.S. Food and Drug Administration (FDA) has been ramping up on-site inspect [...]
In January 2024, the U.S. Food and Drug Administration (FDA) issued a final rul [...]
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue i [...]
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