Forsante Oy’s MDR-certified IRMA decision engine helps automate clinical processes, reduce manual work, and supports more consistent treatment pathways.
We’re proud to have supported Forsante in building its ISO 13485 quality management system and technical documentation aligned with MDR requirements. This is a great example that highlights the value of combining innovation with the right regulatory expertise.
As Antti Särelä, CEO of Forsante Oy puts it, "Aurevia's experts understood the needs of a small company well and were able to tailor solutions that suit us without extra burden. Our collaboration with Aurevia covered everything from building a quality system to compiling a technical file. Our goal was to get an optimally built system that is not too heavy but meets all the requirements."
Read more about this case study, and how Aurevia's experts provided Forsante with tailored solutions to suit their needs.
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