Start an applicable-standards analysis

Raiana Applicable Standards helps you generate a list of standards that may apply to an existing or new medical device. When you open Raiana, the start screen shows analyses you created previously. Review this list if you want to reopen an earlier analysis, or select New Analysis in the upper-right corner. This starts a separate assessment in which you define the regulatory regimes and device information that Raiana will use to identify potentially applicable standards.

Define the regulatory framework and device

On the setup screen, select each regulatory regime in which the device will be active. For example, select the European MDR regime and the FDA regime when the device is intended for both Europe and the United States. Your selections determine the regulatory scope of the analysis. After you select the regimes, Raiana presents standards organizations associated with those regimes and indicates the organizations whose standards will be considered. Raiana does not provide the standards themselves; it uses its information about the standards to determine whether they may apply to the device you describe.

Provide a name

Enter a clear device name in the device-name field. Use a name that identifies the product in your records, such as Raiana Medical Monitor. The name is used to identify the resulting analysis and its exported applicable-standards information.

Provide device information

Provide information that describes the device before continuing. You can upload a document, such as a summary from a submission file or a specification document, so that Raiana can use the document contents during the standards assessment. Alternatively, describe the device directly in the available text area. Explain what the device does and include the information you consider relevant to its intended function. Raiana uses either the uploaded information, the written description, or both to determine which standards may apply.

When you have entered the device information or uploaded the document, select Continue. Raiana then opens a second questionnaire containing additional device-specific questions that can narrow the standards analysis.

Answer the narrowing questions

Review the additional questions and answer them to the best of your ability. You do not have to answer every question: if you leave a question, such as device type, set to Not Sure, Raiana will take that uncertainty into account and continue the analysis. Providing more specific answers can save time and narrow the standards considered.

Use the available choices to refine the device profile. For example, identify the therapeutic area as oncology, indicate that the device is not an active device, and indicate that it does not include software when those answers are correct. These selections can exclude standards that are not relevant to the device.

After completing the questionnaire, or after providing all answers you can reasonably determine, select Start Analysis. This submits the device information and your answers to Raiana’s AI analysis process.

Wait for and review the analysis

The analysis takes several minutes. Raiana first uses your inputs to select the standards that are most likely to be relevant, then uses AI to examine those standards in greater depth and determine which ones are actually applicable. Do not expect the result immediately; wait for the analysis to finish before reviewing it. When processing is complete, open the finished analysis to review the result. The results are presented in an Excel-like table. You can use this table to evaluate each listed standard and record your own final assessment.

For each standard, use the Applicability column to select one of the available classifications: Applicable, Likely applicable, or Not applicable. Review Raiana’s result rather than treating the classification as the final technical-documentation decision, because the checklist is intended for your assessment and completion.

Record justifications and remove entries

Enter a justification for the applicability decision when needed. For example, if the usability and human-factors standard does not apply, select Not applicable and record why. If a record should not appear in the list at all, select the small trash icon for that record. Deleting the record removes it from the displayed list, whereas marking it not applicable and adding a justification preserves evidence that the standard was considered.

After reviewing the standards and completing your edits, save the changes. Use the small arrow in the upper-left corner to return to the main screen after saving; your edited analysis remains available for later review or export.

Export the checklist

When the analysis and your edits are complete, export the list. Raiana generates an Excel sheet containing the applicable-standards checklist. You can add this exported file to the device’s technical documentation.

Open the generated Excel sheet to inspect the exported result. The output is a checklist of the standards identified by the applicable-standards analysis, together with their classifications and the rationale recorded during review.

The checklist includes standards deemed applicable and retains the classifications Applicable, Likely applicable, or Not applicable. For final technical documentation, you must make the final yes-or-no applicability decision and provide the rationale explaining why each standard is or is not applicable.