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AI Assistant app Overview: Difference between revisions
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<strong>AI Assistant app for Medical Device Regulatory Affairs, Quality Assurance, and R&D professionals.</strong> | <strong>AI Assistant app for Medical Device Regulatory Affairs, Quality Assurance, and R&D professionals.</strong> | ||
The AI Assistant app 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. | |||
We invite all community members to contribute to this wiki! It's a space created for everyone using the AI Assistant to share helpful resources. Your contributions will enhance the quality, reliability, and collaboration among users, benefiting us all. | We invite all community members to contribute to this wiki! It's a space created for everyone using the AI Assistant to share helpful resources. Your contributions will enhance the quality, reliability, and collaboration among users, benefiting us all. | ||
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* Assistance with identifying required content based on 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 | * 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 | ||
== Getting started == | == Getting started == | ||