FDA SaMD & PCCP

Navigate FDA conformity for AI/ML medical devices. Learn the Software as a Medical Device (SaMD) framework, the Predetermined Change Control Plan (PCCP) finalised guidance for AI/ML enabled devices (the FDA's solution to continuously learning models), the 510(k) and De Novo regulatory pathways, the Good Machine Learning Practice (GMLP) guiding principles co-developed with Health Canada and MHRA, and the relationship to ISO 13485 quality systems.