EU MDR/IVDR
The European Commission (EC), the European authority in the sphere of medical devices, has proposed a new framework for the use of Artificial Intelligence technology in medical devices. The document is intended to introduce harmonized rules for AI-based medical...
North America
The US medical regulating authority (FDA) finished the discussion on recently published framework for Software as a Medical Device (SaMD) to create a basic guidelines for innovative technologies such as artificial intelligence (AI) and machine learning (ML). Both of...
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...
