Forsante Oy - Case study

CE-marked Class IIb medical device and collaboration with Aurevia 

Forsante's decision engine IRMA and Warfarin Therapy Control Module are classified as CE-marked Class IIb medical devices. The CE marking is an indication that the product meets the safety and performance requirements set by the EU. Class IIb medical devices are high-risk devices whose safety of use has been ensured through comprehensive clinical tests and quality management processes. 

Working with Aurevia has not only made it possible to build a certified quality management system, but it has also brought expertise and resource efficiency to a small company. 

"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."

-Antti Särelä, CEO of Forsante

Forsante has worked closely with Aurevia in the development of the quality management system and the technical file of the equipment for MDR certification. Särelä emphasizes that using an external expert was a cost-effective solution for a small company.

"Hiring our own expert would have been expensive, and the need for resources was not full-time. Outsourcing to Aurevia was the optimal and most cost-effective solution for us."

-Antti Särelä, CEO of Forsante

Forsante's solutions

Forsante PSA is a service that automates the monitoring of prostate cancer. It automatically reminds the patient about their laboratory visit and sends the patient the PSA value and instructions for action by text message. The treating unit monitors its patients through the service and receives an alert if the patient does not undergo laboratory tests or if the specified PSA value or its time series monitoring criteria are exceeded.

Normal cases are handled completely automatically. The PSA service control module is CE marked as an in-vitro device. It is currently in the process of being enhanced and brought under the MDR as a module in MDR IIb CE-marked IRMA.

Based on the MDR-certified IRMA decision engine, Forsante Clozapine ensures safe management of the antipsychotic treatment process. It reminds the patient of laboratory checks, interprets laboratory results, and alerts a professional if necessary. The service implements the proposals for action and dosage recommendations based on the official guidelines of the European Medicines Agency. The solution reduces interruptions in clozapine treatment and reduces treatment costs by reducing laborious and costly restarts.

The Diabetes Treatment Guidance Service being developed for the IRMA decision engine provides treatment recommendations for annual diabetes check-ups and enables the automation of the treatment process.

Forsante's solutions implement approved clinical guidelines, reduce manual work, and allow healthcare staff to focus on more demanding patient cases. Automated processes reduce the risk of human error and ensure consistency in treatment processes.

Future development and research collaboration

Forsante strives to continuously develop its solutions to meet the changing needs of healthcare. The company is also active in research collaborations with various research groups as well as regional public healthcare services.

Forsante's innovative solutions are an example of how technology can improve the quality and efficiency of healthcare services.

For more information:

Mikko Juuti, Account Manager, Aurevia Oy

mikko.juuti@aurevia.com,+358 40 4858826

Antti Särelä, CEO, Forsante Oy

antti.sarela@forsante.com, +358 44 3439566