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 ...

The U.S. Food & Drug Administration issued select updates to premarket cybersecurity guidance on March 13, including who is required to comply, the types of devices that fall under certain agency ...

Life Protect 24/7 is a medical alert system that uses a wearable device to connect the wearer with both emergency and nonemergency help. Share on Pinterest Independence and safety are common concerns ...

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

Navigating the SaMD regulatory pathways is one of the most complex yet important aspects of product development for medical technology startups. Startups in this field are required to meet local ...

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 ...