Tieto Caretech’s Lifecare Journal, a family of openEHR-based clinical applications, is now CE marked as a medical device under the EU Medical Device Regulation (MDR), class IIa. This marks an important step in expanding the deployment of these clinical applications across Nordic and European healthcare markets and provides a regulatory foundation for bringing the applications into new clinical environments and healthcare organizations.
The MDR-certified applications include core capabilities for clinical documentation and patient information management, enabling healthcare professionals to document, access and review patient information as part of their daily clinical workflows.
The openEHR-based applications are part of Tieto Caretech's Lifecare Clinical Suite. The MDR-certification supports their continued development and deployment across healthcare organizations in Nordic and European markets.
MDR requirements cover areas including product safety, risk management and software lifecycle processes, with continued monitoring once the software is in clinical use. For healthcare providers, the certificate provides assurance that regulated clinical applications meet applicable requirements for safety and performance.
From an open data foundation to clinical use
Across Nordic and European healthcare markets, many organizations are seeking ways to modernize legacy healthcare IT environments without replacing all systems at once. Lifecare Clinical Suite is designed to support this transition step by step through open standards, modular applications and interoperable data foundations. The new MDR-certificate demonstrates that this modular approach can also extend to regulated clinical applications.
Important milestone for Tieto
“This is a strong validation of our commitment to deliver safe, compliant and modern clinical solutions for healthcare professionals. It strengthens our ability to support customers both in our existing home markets and as we continue to expand across Europe.”, says Ari Järvelä, Managing Director, Tieto Caretech.
For more information, please contact:
Tieto Newsdesk, news@tieto.com, tel. +358 40 570 4072
Tieto Caretech is a leading provider of health and social care software with strong Nordic roots and a growing European presence. Our smart, flexible, and collaborative Lifecare software supports the daily lives of more than 10 million citizens. With a data-driven approach, we enable care professionals to uncover critical insights and deliver the right support at the right time, ensuring a smoother and more personalized care experience for everyone.
We are part of Tieto, a leading technology company with annual revenue of approximately EUR 2 billion. Tieto’s shares are listed on the NASDAQ exchange in Helsinki and Stockholm.
www.tieto.com