Day: August 17, 2023

In the dynamic landscape of medical device innovation, the utilization of off-the-shelf (OTS) software has become a cornerstone for rapid development and enhanced functionality. However, it is hard for the developers of devices to include most details about the OTS software, the kind of which would be available to in-house software. To allow device developers … Read more

Despite extensive advocacy from the FDA, most pre-approval clinical trials lack diversity owing primarily to the unwillingness of certain segments of the population to participate in clinical trials. However, once a drug is approved by the FDA, its use is more diverse and representative of the demographic distribution of the general population. To take advantage … Read more