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The U.S. Food and Drug Administration (FDA) – in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) – recently hosted a...
What should providers consider when adopting medical devices that rely on artificial intelligence and machine learning?
The 10 principles aim to underline what the agencies describe as “Good Machine Learning Practice” in the same vein as the industry quality standards centered around product manufacturing or clinical testing.
To embed, copy and paste the code into your website or blog: On January 12, 2021, the U.S. Food and Drug Administration (FDA) released the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (Action Plan). The Action Plan expresses that the “FDA’s vision is that, with appropriately tailored total product lifecycle-based regulatory oversight, AI/ML-based Software as a Medical Device (SaMD) will deliver safe and effective software functionality that improves the quality of care that patients receive.” The FDA currently regulates and has a...
Share this article Share this article WALNUT CREEK, Calif., Jan. 12, 2021 /PRNewswire/ -- Exadel (www.exadel.com), a global provider of digital engineering solutions and services, announces a successful 2020 including a burgeoning client portfolio, continued growth, including new executive team members and 2020 sales projections. This year, Exadel gained 24 new clients and many existing clients expanding into new projects. The COVID-19 pandemic created an immediacy for digitization across all industries and verticals giving Exadel an edge with its seasoned product engineering and digital tra...