Validate claims with Raiana Claim Validator

Use Raiana Claim Validator to assess marketing claims and other claims made about a medical device or IVD against evidence in your technical documentation. Before starting, gather the evidence you want Raiana to review, such as complete technical documentation or relevant sections including clinical evaluation reports and verification reports.

Select evidence files

Start by selecting the documents that can substantiate the claims. Select Select Evidence Files to open the file-selection dialog. The dialog displays the files available in your Raiana Enterprise installation, allowing you to choose either a directory or an individual set of files. Include the documentation that contains the technical, clinical, or verification evidence needed for the claims you intend to validate.

After making your selection, click Select in the dialog. The selected files then appear on the left side of the Claim Validator screen. Review this list before continuing so that the evidence set contains the documents against which the claims should be checked.

Validate claims entered as text

Raiana provides two ways to supply claims. For the first method, enter the claims directly as text in the claims area. You can enter multiple claims in one validation request, but place each claim on its own line.

If the review needs to be limited or directed to particular documentation, enter additional instructions before starting. For example, you can request validation from a technical specification document or from clinical documentation. These instructions are optional, but they let you specify the type of evidence that should be considered for the validation.

Click Validate after entering the claims and any additional instructions. Validation first identifies documents in which the claims may be mentioned and then produces a result for each claim. Wait for the validation process to finish before interpreting the results.

Interpret the result

When processing is complete, review each claim’s status and the evidence shown below it. In the demonstrated validation, both claims were approved. For a quick overview, see the coloured result area that displays how many claims are approved, disproved or unknown. See the claim area for an in-depth view of each claim. Treat an unknown result as a warning: because supporting evidence was not found, the claim probably cannot be made without further substantiation. Investigate the underlying documentation and claim wording before using the claim.

To create a portable record of the text-claim validation, click Export PDF Report. Raiana prepares the report after you request the export; the resulting PDF contains the validation information for review or distribution. Report creation can take a few seconds. When generation is complete, download the PDF and open it for review. The PDF presents the same information shown in the Raiana interface, including the result for each claim, the reference documentation, and the location in that documentation where the validation evidence was found.

Validate claims from an uploaded document

The second method is to upload a document that contains the claims, such as a PowerPoint presentation prepared by the marketing department or a brochure. Raiana supports Word, PDF, PowerPoint, and Excel document formats. Select the upload option and choose the document to be reviewed; keep the relevant evidence files selected so the extracted claims can be checked against that documentation.

After the document has been uploaded, click Validate. Raiana first reads the uploaded document and extracts the claims it contains. It then validates each extracted claim against the selected evidence. This means you do not need to retype every claim from a marketing presentation or brochure before starting the review.

Review the extracted claim list before or during processing. The progress message identifies the number of claims being processed, so use it to confirm that the uploaded document was interpreted as expected.

When the report is available, review the result for every extracted claim. In the example, four claims were approved, one was disproved, and two were unknown because no evidence was found.