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)...
FDA
The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices, has published a discussion paper dedicated to the proposed regulatory framework for modifications to the software as a medical device (SaMD) based on the artificial...
IMDRF
The International Medical Device Regulators Forum (IMDRF), a voluntary association of medical device regulating authorities collaborating on the improvement of the existing legal framework, has developed detailed proposals related to the application of quality...
IMDRF
In the course of continuous improvement of the regulatory framework for software as a medical device (SaMD), the International Medical Device Regulators Forum (IMDRF) has developed a new approach to SaMD risk categorization and corresponding consideration. The...
IMDRF
The Medical and Healthcare products Regulatory Agency (MHRA) of the UK has updated the information dedicated to tests and testing kits intended to detect the COVID-19. The information describes how the different types of COVID-19 tests operate and provides...
