AI-Documentation-Assistant: Difference between revisions

'''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.

'''Model description:''' The Documentation Assistant app employs a user-friendly interface with a wizard workflow that solicits the specific type of documentation required from the user. Leveraging this input to understand the device and regulatory context, the Assistant app then consolidates pertinent regulatory requirements and industry best practices, and creates an editable Word document. Subsequently, the user has the flexibility to customize the generated template to incorporate company branding and styles, as well as essential document identifiers, as required.