Applicable standards form the backbone of medical device and IVD technical documentation. As Raiana co-founder Erik Vollebregt explains: “Because not everything can be captured in legislation, the whole thing is based on standards.”

In this feature demo, Erik Vollebregt, CEO and co-founder Maarten ter Mors, and developer Igor Montovani introduce the new Applicable Standards application. They explain how the tool helps regulatory professionals quickly identify relevant standards for a medical device and map them to regulatory frameworks such as EU MDR.

Traditionally, identifying applicable standards is a time-consuming process that requires expert knowledge and extensive manual research. This demo shows how Raiana streamlines this workflow by leveraging AI to analyze device information, assess relevant standards, and generate structured outputs that can be exported and used in technical documentation, potentially saving days of work.