As is already the case under the current EU Medical Device Directive 93/42/EEC (as amended by Directive 2007/47/EC – “MDD”), the purpose for which the software is intended to be used is and remains ...

Charette, who has been writing about software failures for this magazine for the past 20 years, is a renowned risk analyst ...

— -- The prospect of consumers and employees physically losing information-packed mobile devices, or getting them hacked, is driving a red-hot sector of the tech industry: supplying mobile ...

In the waning days of FDA’s fiscal year, the U.S. Food and Drug Administration (FDA) issued the greatly anticipated final guidance “Clinical Decision Support Software,” which aims to clarify the scope ...

Antivirus software offers digital protection and defends against malware. But it can't shield you from everything.

Medical devices have to be designed so that people can use them easily and reliably. Human factors considerations have gained increased attention since the release of FDA's guidance document, Medical ...

Researchers say they have found more than a dozen vulnerabilities in software used in medical devices and machinery used in other industries that, if exploited by a hacker, could cause critical ...

Chinese telecoms giant Huawei Technologies has launched a new app to facilitate seamless data exchange between its ...

Dianna Gunn built her first WordPress website in 2008. Since then, she's poured thousands of hours into understanding how websites and online businesses work. She's shared what she's learned on blogs ...

Apple’s first foldable iPhone is not on sale yet, but the software that would make it feel useful is already hiding inside ...