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

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 ...

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 ...

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 ...