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...
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...
The US FDA announced the launch of a pilot regulatory project related to the “Software as a Medical Device” (SaMD) in the course of amendments to the medical devices certification rules. 2019 Test Plan The development of technologies and regulatory needs are...