Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
(PDF 280KB)In 2021, the U.S. Food and Drug Administration (FDA), Health Canada, and the U.K.’s Medicines and Healthcare products Regulatory...
(PDF 280KB)In 2021, the U.S. Food and Drug Administration (FDA), Health Canada, and the U.K.’s Medicines and Healthcare products Regulatory...