7.6.2026
Orla DTx Oy announces that its Asthma Calculator software has been certified in accordance with the European Union Medical Device Regulation (EU) 2017/745 (MDR) as Class IIa medical device software. The certificate was issued by SGS Fimko Oy (Notified Body 0598) following an assessment of the company’s ISO 13485 -compliant quality management system and medical device technical documentation.
Supporting analysis of lung function measurements
The certified device, Orla’s Asthma Calculator, is a medical device software solution intended to be used for calculation of analytical results relevant for asthma diagnosis and treatment, based on PEF measurement results.
As a Class IIa software medical device, the solution complies with European requirements for safety, clinical performance, and risk management.
The certification confirms that Orla DTx operates under a ISO 13485 -compliant quality management system covering the design, development, manufacture, and maintenance of its software-based medical devices.
Role in the asthma care pathway
Lung function measurements are a central component of asthma assessment, diagnosis, and follow-up. By supporting consistent calculation and analysis of these measurements, Orla’s Asthma Calculator contributes to:
- Systematic handling of measurement data
- Consistent interpretation of lung function results
- Integration of objective measurement analysis into clinical assessment
The Asthma Calculator is part of Orla’s broader service portfolio, where the certified functionality covers the analysis of lung function measurement data.
CEO comment
“This certification confirms that our software meets the requirements for regulated medical use.” said CEO Tuomas Mäkynen. “It supports our focus on providing reliable tools for handling lung function data in asthma care and strengthens the foundation for further development of our services.”
Basis for further development
The certification establishes a regulatory basis for maintaining and further developing Orla’s digital solutions within the MDR regulatory framework, with a continued focus on supporting the use of objective measurement data in asthma care.