40 citations · 137 across the 27 of their papers we have counts for
5 papers · 1 filter
Introducing Traceability in GitHub for Medical Software Development
Vlad Stirbu, Tommi Mikkonen
Assuring traceability from requirements to implementation is a key element when developing safety critical software systems. Traditionally, this traceability is ensured by a waterf…
Extending SOUP to ML Models When DesigningCertified Medical Systems
Vlad Stirbu, Tuomas Granlund, Jere Helén +1
Software of Unknown Provenance, SOUP, refers to a software component that is already developed and widely available from a 3rd party, and that has not been developed, to be integra…
MLOps Challenges in Multi-Organization Setup: Experiences from Two Real-World Cases
Tuomas Granlund, Aleksi Kopponen, Vlad Stirbu +2
The emerging age of connected, digital world means that there are tons of data, distributed to various organizations and their databases. Since this data can be confidential in nat…
On Medical Device Software CE Compliance and Conformity Assessment
Tuomas Granlund, Tommi Mikkonen, Vlad Stirbu
Manufacturing of medical devices is strictly controlled by authorities, and manufacturers must conform to the regulatory requirements of the region in which a medical device is bei…
On Medical Device Cybersecurity Compliance in EU
Tuomas Granlund, Juha Vedenpää, Vlad Stirbu +1
The medical device products at the European Union market must be safe and effective. To ensure this, medical device manufacturers must comply to the new regulatory requirements bro…