MedCity News has published an article by Sara Jaworska, Quality and Regulatory Affairs Senior Manager at DataArt, on the challenges of managing AI-enabled medical devices after approval, including how real-world conditions can affect performance and why ongoing monitoring and change control are essential.
“Even a well-designed validation cannot fully anticipate every patient population, site, or clinical practice the system will face after deployment.”
“Even a well-designed validation cannot fully anticipate every patient population, site, or clinical practice the system will face after deployment.”
“For manufacturers, this means a change control framework cannot focus only on the model while treating the data behind it as a separate issue.”
“For manufacturers, this means a change control framework cannot focus only on the model while treating the data behind it as a separate issue.”
“Authorization of an AI-enabled healthcare product is not a point in time event and will require the manufacturer to monitor and manage the product after its release for clinical use.”
“Authorization of an AI-enabled healthcare product is not a point in time event and will require the manufacturer to monitor and manage the product after its release for clinical use.”
“By understanding how a system is intended to evolve during its development, the necessary steps to validate future changes can be outlined and the appropriate time for further regulatory assessment can be established.”
“By understanding how a system is intended to evolve during its development, the necessary steps to validate future changes can be outlined and the appropriate time for further regulatory assessment can be established.”
Read the full article here.
