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Digital Continuity: Strategies for Product Recall Resilience

Leave a Comment / 04-Product Design & Development, Class 1 recalls, digital continuity, manufacturing, Medical Device, medical devices, MedTech, product design, Product Management, quality management, Quality Management System, RWE, Sponsored Content, supply chain / By

Digital Continuity: Strategies for Product Recall Resilience     The mission to bring meaningful innovation to market and improve patient lives is paired with the requirement that such innovations are held to the highest quality. There were 70 class I U.S. medical device recall events in 2022, a category that the FDA reserves for problems that …

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AI and the Lack of Diversity in Data: Implications and the Path Forward for Rare Disease Research

Leave a Comment / 04-Product Design & Development, 05-Quality/Regulatory, AI/ML, biased data, clinical trials, DCTs, Health Data, Medical Device, MedTech, rare diseases, RWE / By

AI and the Lack of Diversity in Data: Implications and the Path Forward for Rare Disease Research     Artificial intelligence (AI) and machine learning (ML) are poised to be play a pivotal role in clinical trials by automating patient recruitment, data collection and analysis. However, most AI algorithms primarily rely on databases from populations of …

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