The ISO 13485 certificate ensures that the tools, processes and measures used in the software development and production of Kustannus Oy Duodecim’s Integrated Services unit comply with regulations and help to ensure high-quality and safe medical software products.
“We adhere to a quality system that aims to ensure the satisfaction of our customers and other stakeholders. Maintaining quality means, for example, continuous monitoring and improvement of products and processes. The guiding values of our operations are safety, reliability and customer satisfaction, ”describes Eija Kutinlahti, Quality Manager.
“Our goal is to deliver better tools for healthcare professionals and positive health benefits for citizens. The unit’s flagship services, Duodecim EBMEDS (decision support) and Health Benefit Analysis, form a service package that combines these goals, ”says Tuomas Lehto, Business Manager.
“Duodecim is a key player in the national Omaolo service, for which we have provided a symptom assessment of coronavirus disease, among other things. The form has already been filled in more than 300,000 times. Patient safety and reliability must be in order, ”says Anu Suurnäkki, Customer relations manager.
ISO 13485 is an international standard for the design and production of healthcare equipment and supplies. The certificate was granted by SGS Fimko Oy on March 11, 2020. The certificate number is FI20 / 871770.