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This guest post is a collaboration with our friends at Edge Impulse. Edge Impulse shares D5’s passion and vision for modernizing embedded solutions by empowering developers to create and optimize products via embedded development and machine learning.
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Start with the process, Finish with the work To obtain regulatory approval for medical device software, you’ll need to comply with the IEC-62304 Medical Device Software Lifecycle standard. This standard…
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Software Bill of Material (SBOM) for Medical Devices Modern devices are becoming increasingly more complex. Higher user expectations for product features and connectivity have developers looking to include third-party code…
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Part I provides some background to IEC-62304. Part II provides a slightly more in-depth look at some of the specifics. The IEC 62304 Medical Device Software – Software Lifecycle Processes…
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IEC-62304 Software Lifecycle requires a lot of self-reflection to scrutinize and document your development processes. There is an endless pursuit of perfection when it comes to heavily regulated industries. How…
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Creating a proof of concept device is cheap. Creating a device to be submitted through the regulatory path is not, even when it’s the exact same device. The regulatory path…
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