The U.S. Food and Drug Administration has announced the availability of its final guidance on AI medical devices. The document – Marketing Submission Recommendations for a Predetermined Change Control ...

In the document, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning-Enabled Device Software Functions," the FDA proposes to ...

Figure 1. (click to enlarge) Part-level flow simulation. The diversity and complexity of medical devices are likely to increase with time, as will the associated design risks and manufacturing ...

CyberActa medical device software design and development expertise minimizes vulnerabilities and reduces attack surface of every phase of the development cycle ...

Due to the increasing concerns about medical devices' cybersecurity risks, European Union regulators put forward a new set of market entry requirements for medical devices and in vitro diagnostic ...