Quality and compliance

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.

Our development work is guided not only by user experiences but also by the local requirements.

Our certificates

MDR 

Certain modules of our Mediconsult Saga® and Mediconsult Mediatri Saga® 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.

ISO 13485

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.

ISO 27001

Mediconsult has been certified according to the ISO 27001 information security standard . This internationally recognized standard demonstrates that the company’s information security management is systematic, independently audited, and subject to continuous improvement.

ISO 27001 certification confirms that Mediconsult has implemented a comprehensive information security management system. This ensures that information is handled confidentially, its accuracy and integrity are maintained, and it is accessible to authorized parties when required.