Conformity assessment of medical device software and AI
With the emergence of artificial intelligence in medical device software, manufacturers are facing challenges to meet regulatory requirements in an evolving regulatory landscape.
![AI Medical Device Software under the MDR](/siteassets/images/ai-medical-device_1134x300px.jpg?mode=crop&scale=both&quality=90&format=webp&width=820&height=471)
AI Medical Device Software under the MDR
Read our recommendations regarding automation bias and performance conformity assessment of AI medical device software in a changing regulatory landscape.
![Clinical decision support software](/siteassets/images/clinical-decision-support-software-358pxl-side-image.jpg?mode=crop&scale=both&quality=90&format=webp&width=820&height=471)
Clinical decision support software
Regulatory landscape in Europe from May 26th 2020
![Towards trustworthy industrial AI systems](/siteassets/images/towards-trustworthy-industrial-ai-systems---2560x1440.jpg?mode=crop&scale=both&quality=90&format=webp&width=820&height=471)
Towards trustworthy industrial AI systems
Read our position paper giving perspectives on what needs to be considered in developing verification processes and the assurance of AI systems in industrial contexts.