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<strong>AI Assistant app for Medical Device Regulatory Affairs | <strong>AI Assistant app for Medical Device Regulatory Affairs, Quality Assurance, and R&D professionals.</strong> | ||
Here's a breakdown of the AI Assistant app key | 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. | ||
Here's a breakdown of the AI Assistant app key capabilities: | |||
'''Trend Analysis and Reports (AI-Analysis-Assistant):''' | '''Trend Analysis and Reports (AI-Analysis-Assistant):''' | ||
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* Assistance with Process Hazard Analysis (PHA) and Failure Mode and Effect Analysis (FMEA) for design, usability, and process-related risks. | * Assistance with Process Hazard Analysis (PHA) and Failure Mode and Effect Analysis (FMEA) for design, usability, and process-related risks. | ||
The AI Assistant empowers | '''Documentation Assistant (AI-Documentation-Assistant):''' | ||
* Create documentation templates for medical device files containing guidance information for critical content to be included. | |||
* Improve team efficiency and promote consistency within the medical device files. | |||
* Assistance with applicable regulations and state-of-the-art standards. | |||
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. | |||
== Getting started == | == Getting started == | ||
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* [[AI-Complaint-Assistant for document]] | * [[AI-Complaint-Assistant for document]] | ||
* [[AI-Risk-Assistant]] | * [[AI-Risk-Assistant]] | ||
* [[AI-Documentation-Assistant]] | |||