FDA
The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices and healthcare products has published an action plan on Software as a Medical Device (SaMD) based on the Artificial Intelligence / Machine Learning (AI/ML)...
North America
The last AI/ML blog described the basics, regulation, and premarket submission / modification. This blog will be discussing the risk categorization and TPLC (Total Product Life Cycle) of AI/ML-based SaMD. Artificial intelligence and machine learning is a new and...
North America
Artificial intelligence (A.I.) is an advanced field of science that has influenced various areas. The concept of implementing artificial intelligence in the healthcare has only recently been emerging. The medical field aims to use the power of A.I. to provide more...
