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::; <h4>[[AI-510(k)-Assistant]]</h4>:<i>** Last updated 04/30/2024</i><br/>Automates 510(k) submission content preparation for eSTAR compliance. Extracts data from predicate device summaries, identifies similarities, and guides users in filling submission forms. Streamlines regulatory compliance and accelerates the submission process. | ::; <h4>[[AI-510(k)-Assistant]]</h4>:<i>** Last updated 04/30/2024</i><br/>Automates 510(k) submission content preparation for eSTAR compliance. Extracts data from predicate device summaries, identifies similarities, and guides users in filling submission forms. Streamlines regulatory compliance and accelerates the submission process. | ||
::; <h4>[[AI-Watchdog-Assistant]]</h4>:<i>** Last updated 05/30/2024</i><br/>Watchdog Assistant scours websites you specify, mining for new information that matches your set criteria (keywords, dates, categories). It then creates clear, concise summaries and delivers them straight to your inbox via email. | ::; <h4>[[AI-Watchdog-Assistant]]</h4>:<i>** Last updated 05/30/2024</i><br/>Watchdog Assistant scours websites you specify, mining for new information that matches your set criteria (keywords, dates, categories). It then creates clear, concise summaries and delivers them straight to your inbox via email. | ||
::; <h4>[[AI-QMSR-Gap-Assistant]]</h4>:<i>** Coming Soon.</i><br/>Stay ahead of the curve! The AI-QMSR Gap Assistant is currently under testing, and it is specifically designed to simplify your QMSR transition path. This AI-powered tool will scour your QMS documents and identify potential gaps against ISO 13485:2016 requirements and QMSR Subpart B – Supplemental Provisions, ensuring you're well prepared for the February 2nd, 2026 deadline. | |||