How is PENTA project Vivaldy developing efficient re-verification & re-validation strategies in the medical domain?
During the first year review meeting, the project demonstrated the automated fast configuration switching on the virtual test platform. This is now available to view here.
The Vivaldy (VerIfication and Validation of Ai-enabLeD sYstems) project is developing efficient re-verification & re-validation strategies and effective regulatory approval guidelines for the incremental upgrade of class II, AI-enhanced CPSs in the professional healthcare domain. Based on a ‘DevOps’ approach, it will enable rapid incremental dissemination of innovations, increasing the frequency of major system upgrades from every three years to once a year, and module and/or AI upgrades from once a year to every six months. This will lead to better responses to fast-changing public health challenges, along with improved patient engagement and quality of care, while ensuring patient safety remains paramount.
Increasingly, products of all kinds – from consumer appliances to medical devices – are becoming intelligent, connected, and linked to the physical world. They incorporate Cyber Physical Systems (CPS) which interact directly both with embedded intelligence and with the real-world physical environment. Today, advanced CPS are characterized by frequent incremental upgrades (software, hardware and modules) after the initial product release, and by the addition of Artificial Intelligence (AI) to enhance their utility. This poses challenges in applications such as professional healthcare. With patient safety of paramount concern, class II medical devices must undergo certification to demonstrate that they comply with stringent safety requirements. However, there are currently no regulatory guidelines for incremental upgrades. This limits the ability of such devices to be upgraded rapidly to respond quickly to emerging public health challenges and to benefit from evolving advances in CPS and AI. Moreover, if upgrades are carried out, the evidential value of the initial verification and validation (V&V) required for certification is rapidly lost.
Find out more about Vivaldy.