Posts categorized as“Software”

James Sease

The Value of SBOMs and SBOM Analysis

The FDA recently published a new guidance on Cybersecurity and software in medical devices: “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”. The new guidance has pushed software composition and vulnerabilities up in importance when making a submission to the FDA. As such, Software Bills of Materials (SBOMs) have become a […]

Dendy Addison

Creating a Medical Device Bootscreen for QNX

Most if not all major devices (including medical devices) throughout the world have some form of a bootscreen. This often flashy but sometimes simple animation performs two purposes. One is simply that it looks good, plus companies can personalize and add their branding to it. But the second reason is arguably more important; it lets […]

Russell Haley

Overview of the New FDA Guidance on Cybersecurity

“Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | FDA” is a new document produced by the FDA that provides guidance on integrating cybersecurity into the quality system management and premarket submission process for medical devices. It covers risk management, design controls, software validation, and other elements to ensure the safety, […]

Thor Tronrud

Using Language Models (AI) Responsibly In Medical Devices

Generative language models, colloquially known as “AI”, have been making waves across many different sectors in a wide range of roles, ranging from customer support chatbots to programming assistants, and even to a new wave of web search tools. The invasion of so many (large language model) LLM-based products has also sparked furious debate about […]

James Sease

Design for Testability

Many different aspects must be considered when designing a medical device. This is particularly true with more complex devices that rely on internal computers to support their function. Every device must be safe, effective, affordable, easy to use, etc. But one aspect that can be overlooked in favor of the shinier factors is testability. Design […]

Levi Puckett

3 Git Tips to Improve Medical Device Software

Medical device software is very diverse. From low-level firmware drivers to data analysis and AI, to web development and cybersecurity, the technologies are wide ranging, each with their own quirks. In all this variety, one technology is ubiquitous: Git! Your version control system (VCS) is always there, and it’s worth taking a bit of time […]

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