LLM-based medical devices can transform healthcare
Our expert team knows how to certify GenAI. We’ve written about how innovators can harness the power of the leading LLMs for their SaMD
Can your medical device use ChatGPT and still get certified under EU MDR?
Not easily, but yes they can. Read the case for third-party LLMs in AIaMD
LLMs as SOUP (software of unknown provenance)
Read why LLMs are usually treated as SOUP when incorporated into medical software and how to handle their unique challenges
Guiding principles for technical and clinical evaluation of LLMs as a Medical Device
Learn the key approaches to assessing GenAI-based medical devices under EU MDR
Need to certify a software medical device?
Schedule a call or demo, or simply get more info about the Scarlet process and platform.