Posts by James Sease

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 […]

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 […]

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