In medical-device software, an update isn’t just a new feature — it can directly affect patient safety. Every code change in a surgical-laser system must be fully traceable to its verification and ...

On October 18, 2018, FDA released a new draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which describes the Agency’s current thinking and ...

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 ...

FDA has an impressive collection of ongoing digital health initiatives, and the regulation of software and hardware has evolved greatly since smartphones and tablets were launched about a decade ago.

Over 300,000 new types of ransomware and other malicious software are discovered daily, according to the IT security research institute AV-TEST. Computer viruses can slow your devices, create a slew ...

We missed this earlier: On October 21, the Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare (MoHFW), released draft guidelines for granting licences ...

In anticipation of FDA’s virtual public workshop on transparency of artificial intelligence/machine learning (AI/ML)-enabled medical devices scheduled for October 14, 2021, we will be posting a series ...

Value stream management involves people in the organization to examine workflows and other processes to ensure they are deriving the maximum value from their efforts while eliminating waste — of ...

Worldwide IT spending this year will rise 3.2 percent to US$3.8 trillion, driven by rebounding device sales and strong growth in the enterprise software category, according to analyst firm Gartner.