Life Science Daily News has published an article by Sara Jaworska, Quality and Regulatory Affairs Senior Manager at DataArt, examining the regulatory challenges of integrating third-party large language models into medical devices, including manufacturers' responsibilities for clinical validation, model changes and ongoing compliance across the US, UK and EU.
“The technology may be outside of the manufacturer’s control, but the manufacturer remains responsible for the safe use of the medical device in the clinical environment.”
“The technology may be outside of the manufacturer’s control, but the manufacturer remains responsible for the safe use of the medical device in the clinical environment.”
“Even if the original vendor publishes extensive performance data across many use cases, it will not necessarily transfer to the specific use case of the medical device.”
“Even if the original vendor publishes extensive performance data across many use cases, it will not necessarily transfer to the specific use case of the medical device.”
“Before relying on an external LLM, manufacturers therefore need to understand how they will be notified of relevant changes and whether the validated version will remain available for as long as they need it.”
“Before relying on an external LLM, manufacturers therefore need to understand how they will be notified of relevant changes and whether the validated version will remain available for as long as they need it.”
“The manufacturer may have little say in how the underlying model is built, but full say in how it is used inside their own device, and that choice is worth making early, before the product depends on it.”
“The manufacturer may have little say in how the underlying model is built, but full say in how it is used inside their own device, and that choice is worth making early, before the product depends on it.”
Read the full article here.
