Digia strengthens its competitiveness in healthcare and social services – ISO 13485 complements comprehensive service portfolio
The new ISO 13485 medical device certification supports the company's position as a technology partner for demanding and regulated industries. ISO 42001 certification of the AI management system is also being prepared.
Digia's comprehensive management and quality management system is expanding. In addition to the ISO 9001 quality and ISO 27001 information security certificates already in use, the company has been awarded the international ISO 13485 certificate for medical devices.
The certificate covers the design, development, deployment, maintenance, support, and distribution of the software solutions and digital services of Digia's subsidiary, Productivity Leap, in regulated medical device operating environments.
Productivity Leap and Digia have been working with various social welfare and healthcare operators for a long time. Companies develop, for example, data and information management of the wellbeing services counties, as well as knowledge-based management, integrations, automation, various AI solutions, and modern customer applications and services.
"The certificate is an indication of our ability to provide our customers in the social and health care sector with services related to medical devices that consistently meet standardized customer and regulatory requirements," says Kari Natunen, CEO of Productivity Leap.
Audited operating models bring concrete certainty to customers' everyday lives
With the certificate, Digia has operating models for the pharmaceutical and health technology environment that have been tested in practice and verified through audits, strong regulatory expertise, and documentation capabilities. In addition, the company has a ready-made foundation for scaling services that meet ISO 13485 requirements.
"Our quality management system is an integral part of our everyday life. These are not just standards, but also certified, audited, and proven operating models that provide concrete certainty to our customers," says Samuli Savolainen, Vice President, Operations, Digia's Managed Solutions business unit.
Digia combines the requirements of different standards into a single, integrated management system. A common operating model helps to ensure quality, safety, and systematic management of requirements.
"With the help of our management system, we develop our operations and services and effectively integrate proven practices into customer deliveries. Next, we will advance the responsible and controlled use of AI by preparing for ISO/IEC 42001 certification," Savolainen says.
Further information:
Kari Natunen
CEO, Productivity Leap Ltd.
tel. +358 40 836 9962, kari.natunen(a)digia.com
Samuli Savolainen
Vice President, Operations, Managed Solutions, Digia Plc.
tel. +358 40 086 1355, samuli.savolainen(a)digia.com
Learn more about sustainability at Digia
Digia is a trusted European partner in intelligent business. As a consulting, software and services company, we help our customers to create, maintain and develop intelligent business. We bring the benefits of AI to our customers' everyday processes, products, and services throughout their lifecycles. Our approximately 1600 employees operate internationally, yet always close to our customers. Digia’s net sales totalled EUR 217.0 million in 2025. The company is listed on NASDAQ Helsinki (DIGIA).