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, ...

Mobile device management creates a standard setting for corporate owned mobiles, tracks their location, and enforces security. Systems can also manage BYOD. Find out the best MDM system. Businesses ...

Tandem Diabetes Care issued an urgent medical device correction to upgrade the software of its Tandem Mobi insulin pumps that ...

Discover how entitlement management systems help vendors meet EU CRA, MDR, and FDA cybersecurity requirements while ...

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 ...

The 2023 State of Cybersecurity for Medical Devices and Healthcare Systems report, a collaboration of the Health Information Sharing and Analysis Center with Securin and Finite State, examined the ...

Kimberlee Leonard has 22 years of experience as a freelance writer. Her work has been featured on US News and World Report, Business.com and Fit Small Business. She brings practical experience as a ...

On June 14, 2023, FDA finalized its “Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff” (the “2023 Final Guidance”). The ...

Draft guidelines aim to align India's medtech software framework with global practices; industry seeks more clarity on AI/ML ...

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 ...