Sirma Medical Systems, developer of the Diabetes: M mobile app and monitoring platform, received a certificate for quality control in compliance with ISO 13485:2016, indicating that the system meets the most current regulatory requirements for the design, development, distribution, and maintenance of software for medical purposes. The audit of the company was performed by the international certification authority Lloyd’s Register.

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

This milestone is yet another confirmation of Sirma Medical Systems as a reliable provider of medical software systems on the international market. We always strive to improve our work processes and quality control during all stages of the development of our products and services.

This certificate gives assurance to our users, customers, and partners that the company’s products and services meet the highest international requirements for quality and safety.“, commented Rosen Varbanov, CEO of Sirma Medical Systems.


Sirma Medical Systems, founded in 2016 as a part of Sirma Group Holding, develops modern software applications and integrated platforms for tracking and control of chronic diseases. With its creation, the company acquired one of the most popular apps for diabetes monitoring and control – Diabetes:M, which automatically made the company one of the leaders in this segment of the mHealth market. Applications, such as Diabetes: M are incorporated into Sirma’s single, integrated platform to track vital parameters needed by patients and doctors as well as provide clear data visualizations and dashboards for easy use.