When device modifications could affect safety and effectiveness, a premarket notification submission is required.
The demands of a connected device means product designers should change their approach to software development.
No medical device is 100% secure.
The design history file establishes the baseline for the design and development of a device.
Skip the Xanax—transcranial electrical stimulation might be able to help.
APRIL FOOL’S: This article was part of our special edition, Find the Fake News.
The rise in cancer cases has led device companies to form partnerships to distribute their products in the region.
Companies should not underestimate the importance of investing in user experience design.
Healthcare providers are being warned about an increased rate of adverse cardiac events, as the agency conducts additional analyses.
Devices that help treat respiratory problems are in high demand.