September 17, 2024 – Biocogniv, a leading innovator in AI-based diagnostics, has achieved continued ISO 13485:2016 certification in July 2024, following its initial certification in October 2023. ISO 13485:2016 is the global standard for medical device quality management systems, critical for ensuring consistent product safety and performance.
This milestone underscores Biocogniv’s commitment to regulatory excellence as the company continues pursuing FDA clearance for its Sepsis aiMarker™, which received FDA Breakthrough Designation in 2022. Achieving and maintaining ISO 13485:2016 is a significant step for Biocogniv in advancing toward market approval, enhancing credibility, and demonstrating its capacity to meet stringent medical device standards.
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