12 février 2024
info:eu-repo/semantics/openAccess
lsgilbert, « MHRA and international partners publish five guiding principles for machine learning-enabled medical devices », ELSIBI, ID : 10.58079/vtbs
The Medicines and Healthcare products Regulatory Agency, US Food and Drug Administration and Health Canada have collaborated to identify five guiding principles for the development of predetermined change control plans (PCCPs). These guiding principles for PCCPs aim to remove the regulatory burden for developers of machine-learning-enabled medical devices, enabling reallocation of resources to improve product performance for patients. Read the news story from Medicines and Healthcare product...