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AI-Documentation-Assistant: Difference between revisions
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==App Files== | |||
<blockquote> | |||
Application executable: [[Media: AI-Documentation-Assistant.zip]] | |||
</blockquote> | |||
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See the sample files page for example templates. | |||
'''[[Sample Files: AI-Documentation-Assistant]]''' | |||
==App Description== | |||
'''Use case:''' The AI-Documentation-Assistant creates comprehensive documentation templates for medical device files. It aims to streamline the documentation process, enhance team efficiency, and ensure consistency by providing guidance on required content. The documentation templates created are based on relevant regulations such as FDA cGMP, ISO 13485:2016, and EU MDR/IVDR for the user requested type of documentation. Additionally, the Documentation-Assistant app assists in aligning documentation content with state-of-the-art standards such as ISO 14971:2019, IEC 62304, and IEC 62366, among others. | '''Use case:''' The AI-Documentation-Assistant creates comprehensive documentation templates for medical device files. It aims to streamline the documentation process, enhance team efficiency, and ensure consistency by providing guidance on required content. The documentation templates created are based on relevant regulations such as FDA cGMP, ISO 13485:2016, and EU MDR/IVDR for the user requested type of documentation. Additionally, the Documentation-Assistant app assists in aligning documentation content with state-of-the-art standards such as ISO 14971:2019, IEC 62304, and IEC 62366, among others. | ||
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A Word document is generated containing the requested document template. | A Word document is generated containing the requested document template. | ||