Choose the regulatory framework and thinking effort

Begin by opening the regulatory-framework selector in the chat interface. Select the framework that applies to your question: MDR, IVDR, FDA, AI-Act and STRATI. The selected Agent determines the regulatory context Raiana uses when answering your inquiry, so choose the framework that matches the subject of your work.

When the selector is open, choose the required Agent from the available options. STRATI provides access to more regulations than the initially listed frameworks. If you select STRATI, use its additional regulation-selection control to include all available regulations or select only the regulations relevant to your question; this selection can also include MDR, IVDR and FDA.

In the same configuration area, set the thinking effort for the answer. Auto is selected by default and allows Raiana to determine how much effort the question requires. Select Low for a simple inquiry that generally needs a short answer, Medium for a more in-depth answer at approximately chapter level, or High when you want Raiana to analyze every possibility.

Toggle the globe icon to enable or disable web search. When you want to consult new documentation that might not be in Raiana’s database yet, Raiana will consult reputable sources to find the documentation. It is illuminated when enabled.

Click the plus icon on the left side to attach files to your query. You can then ask questions that will consider your documentation, so you don’t have to enter everything manually. You can also ask questions about your technical documentation to save time and effort, such as what device class your device is.

Ask a regulatory question

Enter your regulatory question in the prompt field. Formulate the prompt with enough context for the selected Agent to understand the product, regulation, or compliance issue you are investigating. When the prompt is ready, submit it by selecting the arrow button or pressing Enter.

After submission, Raiana displays its reasoning activity while it works on the request. The reasoning view can show how Raiana understood the query and the work it is performing, including retrieval of additional documents from the internet when that activity is used. Allow the reasoning process to complete before evaluating the generated answer.

When reasoning is complete, the answer begins to generate in the conversation. Read the response in the context of the question and the selected Agent. Regulatory answers should be reviewed by an appropriately qualified professional before they are used for a compliance decision. Raiana may display underlined areas within the answer. Select an underlined reference to open the corresponding regulation in a separate browser tab, where you can inspect the cited regulatory source directly. Use the reasoning control associated with the answer to display the reasoning process again after generation. This provides a way to examine how Raiana approached the query and can help identify where an answer may have gone wrong.

Attach and manage files

Open the attached-files area to see which files are currently associated with the chat. The area shows the number of attached files; a chat can have zero attached files or files selected from an imported folder.

To add supporting material, use the file attachment control and choose a folder that has already been imported. Select the files required for the question, then add them to the chat. The selected files become available as supporting material for the conversation.

If the required files or folders are not ready, use the folder controls to create a folder. Refresh the folder list when its contents or availability do not appear up to date. Folder management also lets you change a folder name, delete a folder, and add more files with the file-add control.

Verify an answer

Each generated answer has a Verify control below it. Select Verify to have a second, seperate AI check the answer. The likelihood of two unrelated AI systems hallucinating the same information is considered nearly zero, but verification does not replace professional review of the answer, its sources, or its applicability to your product and regulatory situation.

Start and find chats

Select New chat in the sidebar to begin a separate conversation. Starting a new chat does not replace the current conversation: the current chat is saved in Raiana’s chat records and chat history, allowing you to return to it later. Open Chat history to view previous conversations. Use the search control, represented by a magnifying-glass icon, to locate a particular chat. You can also sort the history by time, by project, or by bookmarked status to narrow the list to the records most useful for your work.

Use the selection controls to select multiple chats or records at once. After selecting them, move them to a project or delete them in one operation. For an individual record, hover over it to reveal the three-dot menu, which provides actions such as renaming, bookmarking, deleting, and adding the record to a chat or project.

Create and use projects

Select the Projects button in the sidebar to open the project area. Create a new project and provide a name. You can also enter an optional description, which is useful when several people in your company use the same project and need additional context about its purpose. Configure the project by choosing its Agent, regulation, and instructions. Project instructions can constrain the format or style of every response, such as requiring the answer to contain only three paragraphs and what you need. Review these settings carefully because they are intended to guide questions asked within the project. Add files below the instructions when all chats in the project should use the same supporting material.

After creating a project, you can adjust its settings, delete it, or add more users so colleagues or clients can work with the same project. Use these project-level controls to maintain the shared regulatory context and files as the work changes.

Ask a question from within the project to use the project’s files and instructions automatically. For example, ask, “What is the device classification of my products?” Raiana opens a new chat for the project question, and the resulting response follows the configured project instructions and uses the project files.