Jun 12 - 5:21
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...
Jun 5 - 5:25
Pre-cert Program, or also known as the Software Precertification Pilot Program (Pre-Cert), was first mentioned in the FDA’s Digital Health Innovation Action Plan. The purpose of this pilot program is to create a...
Jun 4 - 5:14
European Medicines Agency issued a new draft guidance related to drug-device combinations. This particular regulation specifies the necessary documents for the application for marketing authorization for these types of...
May 30 - 4:05
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...
May 29 - 2:39
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...
