The agency cited quality issues at facilities testing Dexcom’s G6 and G7 monitors, including inadequate validation and risk ...
On December 18, 2024, the Company announced the submission of its 510 (k) premarket notification to the U.S. Food and Drug Administration (FDA) for review and clearance of its Intelligent ...
Kneat's SaaS model automates validation processes in pharma and biotech, reducing errors and ensuring compliance. Learn why ...
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