Asia
The Health Sciences Authority, Singapore’s agency in the sphere of medical devices, announced public consultations on the risk classification of Standalone Medical Mobile Applications (SaMD) and qualification of Clinical Decision Support Software (CDSS). The present...
Asia
The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has initiated a public consultation on the risk classification of standalone medical mobile applications (SaMD) and qualification of clinical decision support...
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...
