40 citations · 73 across the 5 of their papers we have counts for
6 papers
Towards regulatory compliant lifecycle for AI-based medical devices in EU: Industry perspectives
Tuomas Granlund, Vlad Stirbu, Tommi Mikkonen
Despite the immense potential of AI-powered medical devices to revolutionize healthcare, concerns regarding their safety in life-critical applications remain. While the European re…
Continuous Design Control for Machine Learning in Certified Medical Systems
Vlad Stirbu, Tuomas Granlund, Tommi Mikkonen
Continuous software engineering has become commonplace in numerous fields. However, in regulating intensive sectors, where additional concerns needs to be taken into account, it is…
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…