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 ...

Image Acquisition, Contextual Indexing, Differential Analysis and Exception Routing Designed to Move Quality Decisions ...

Software-based medical devices are integral to healthcare. To enter the marketplace, a company must successfully navigate and comply with applicable national and international regulatory requirements.

Imagine a medical device that can answer questions, summarize patient records, suggest next steps, and interact with users ...

This article is authored by Dr Ashok Kumar Moharana, chief medical officer, Healthium Medtech Ltd.

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 ...

Updating software as new vulnerabilities are discovered persistently remains a top cybersecurity challenge involving medical devices, said David Brumley, a cybersecurity professor at Carnegie Mellon ...

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 ...

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 ...

Medical device companies should treat copyright as just one part of a layered protection strategy. The DMCA repair exemption preserves ...