There has been a surge in academic and business interest in software as a medical device (SaMD). It enables medical professionals to streamline existing medical practices and make innovative medical ...

Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

The software supply chain is critical to ensuring a secure medical device that can prevent injury, according to Gregg Van Citters, MS, PhD, a principal software quality engineering consultant at ...

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 ...

The latest update to the Federal Drug Administration (FDA) for medical device cybersecurity mandates the development of a software bill of materials (SBOM). This provision can be a significant ...

As the biopharma space gets more competitive and the days of blockbuster drugs seem further in the rearview, biopharma companies are investing in digital to find new and innovative ways to ...

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 ...

Because it is getting harder to underestimate "the evil genius of the modern-day cybercriminal," Eracent, which develops asset management tools for software and IT, says it will offer healthcare ...

Hacking pacemakers and insulin pumps is mostly hype; thankfully the scary stories are just that, scary possibilities that could supposedly happen if attackers were to target vulnerable devices. Some ...

CDSCO formalises algorithm change protocol to streamline AI/ML software updates: Peethaambaran Kunnathoor, Chennai Friday, ...

The International Medical Device Regulators Forum, a medical device-focused regulators-only successor group to the Global Harmonization Task Force (GHTF), has released a new document for consultation ...

It is no longer possible to ask the FDA to keep pace with software development by doing the same reviews faster,” writes Dana ...