Quality

For us, quality management means integrating the planning of operational activities and leadership as an essential part of all our operations and the entire organization.

High-level data security is a component of the quality system and an integral part of our activities and solution development. Our patient information systems, the services we offer, and our organization are audited annually. In addition to audits, we conduct regular internal and external inspections to identify potential security vulnerabilities.

Certain modules of our Mediconsult Saga® and Mediatri systems are classified as medical devices under the MDR regulation and have been granted MDR certification. This demonstrates our long-term commitment to adhering to the highest safety and quality standards in our operations. The certification has been awarded by SGS Fimko Oy.

The MDR (Medical Devices Regulation) is a European Union regulation concerning all manufacturers of medical devices. Software, such as patient information systems, are also considered medical devices when they meet the definition of a medical device.

The MDR regulation is regarded as one of the strictest requirements for medical device manufacturers. MDR sets very high standards for safety, quality, and performance. Meeting these requirements ensures that our social and healthcare information systems operate efficiently and are safe for both patients and healthcare professionals throughout their lifecycle.

Mediconsult has been awarded the ISO 13485 quality certificate, an international management system standard for the design and production of healthcare devices and supplies. Additionally, the modules in our system identified as medical devices are CE marked.

Our development work is guided not only by user experiences but also by the national requirements and projects of the Ministry of Social Affairs and Health (STM), the Social Insurance Institution of Finland (Kela), and the National Institute for Health and Welfare (THL).