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AI Assistant app Overview: Difference between revisions
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'''Documentation Assistant (AI-Documentation-Assistant):''' | '''Documentation Assistant (AI-Documentation-Assistant):''' | ||
* Create documentation templates for medical device files containing guidance information | * Create documentation templates for medical device files containing guidance information. | ||
* Improve team efficiency and promote consistency within the medical device files. | * Improve team efficiency and promote consistency within the medical device files. | ||
* Assistance with applicable regulations and state-of-the-art standards. | * Assistance with identifying required content based on applicable regulations and state-of-the-art standards. | ||
* Content guidance based on well established quality standards and regulations such as FDA cGMP, ISO 13485:2016, ISO 14971:2019, IEC 62304, IEC 62366, IEC 60601 series, ISO 15223-1, ISO 10993 series, ISO 14155, IEC 81001-5-1, and EU MDR/IVDR | |||
The AI Assistant empowers medtech professionals to work more efficiently and consider factors from hundreds of thousands of data points, promoting a data-driven approach to premarket regulatory compliance and post market surveillance. | The AI Assistant empowers medtech professionals to work more efficiently and consider factors from hundreds of thousands of data points, promoting a data-driven approach to premarket regulatory compliance and post market surveillance. | ||