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 ...

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...

The goal of medical device software development should be to select a process and architecture that ensure a safe and effective product. The methods utilized to achieve this goal differ among medical ...

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 ...

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 FDA released their updated guidance on Cybersecurity in medical devices: Quality System Considerations and content for Premarket submissions at the end of June in 2025. In this guidance the FDA ...

Medical software is the backbone of modern healthcare, supporting electronic health records (EHRs), diagnostic systems, imaging technologies and embedded software in medical devices like pacemakers ...

On September 27, 2023, FDA finalized its guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (the “2023 Final Guidance”). 1 The ...

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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 ...