RAISE apps
RAISE is the Regulatory Augmented Intelligence System Executive. We promise you that that phrase existed before the acronym.
These apps perform high-level tasks such as the ones you do every day in regulatory practice.
The apps are part of the Raiana Pro and Raiana Enterprise plans. Find out more here. The distinction is that apps that read files – for example, technical documentation assessment – are available on Raiana Enterprise only.
More apps will be added as they come out, so watch this page!
Don't just chat. Get work done.
Vigilance
Assess if an incident report from the field requires reporting. When to report and to whom. Determine which questions need to be answered for reportability. Supports EU, UK, CH and US jurisdictions.
For Raiana Pro and Enterprise
Available February 2026
Classification
Get a rule-based report for the classification of your device. See which things to avoid to prevent higher classification and what can be done to lower the existing classification, if possible.
For Raiana Pro and Enterprise
Available now (FDA) and March 2026 (MDR/IVDR)
Marketing claim checker
Verify marketing claims based on evidence in your technical documentation. Obtain references to where in which document the claim is supported.
For Raiana Enterprise
Available March 2026
Consistency checker
Get an overview of consistent terminology like intended purpose and patient population across your entire technical documentation.
For Raiana Enterprise
Available March 2026
