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 ...

On October 18, 2018, FDA released a new draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which describes the Agency’s current thinking and ...

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 ...

As the number of malware and ransomware attacks rise, it is as important to make sure that your organization and personal data is not only being protected, but also being prepared in the event data is ...

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 ...

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 ...

The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical technologies. This article examines the 2024 guidelines from the U.S. Patent and ...

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 ...

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

The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on Medical Devices Software, under the Medical Devices Rules (MDR), 2017, to bring in specific regulatory ...

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 ...

Following up on work commissioned by the U.S. Defense Advanced Research Projects Agency (DARPA), IBM has developed a programming paradigm, and associated simulator and basic software library, for its ...