Medical apps, treatment planning software, and even firmware for ultrasound devices: software is legally classified as a medical device if it is used for medical purposes. This includes diagnosing, ...

Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

The intended use of medical device software will dictate its regulatory path, and engineering teams should be aware of such ...

There was a time when CES' annual takeover of Las Vegas was about as reliable as the passing of seasons, but the COVID-19 pandemic has transformed this year's event into the first all-digital show of ...

PCCPs allow device manufacturers to implement preapproved modifications to their devices in lieu of obtaining separate authorizations for each significant change prior to implementation. A PCCP ...

One of the more mysterious aspects of using multiple Apple devices comes when you connect an iPhone, iPad, or iPod touch to a Mac and are greeted with a dialog from an app called MobileDeviceUpdater ...

Medtronic identified an issue with its CareLink SmartSync device manager providing inaccurate longevity estimates for certain leadless pacemakers. Customers can download a software update to resolve ...