Medical Device Development

Medical Devices with Machine Learning?

May 16, 2023

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

December 10, 2020

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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Medical devices in an operating room

Software Bill of Material (SBOM) for Medical Devices

November 18, 2020

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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Medical Device Documentation

October 21, 2020

  Working on a medical device is a large undertaking. The documentation required by the FDA is able to intimidate even the most stalwart engineer all on its own. But…

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Operating room filled with medical devices

IEC-62304 Medical Device Software – Software Life Cycle Processes Primer – Part II

August 12, 2020

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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Medical device monitoring vitals

IEC-62304 Medical Device Software – Software Life Cycle Processes Primer – Part 1

August 10, 2020

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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How much is that medical device going to cost!?!??!

July 1, 2020

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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Accelerating Medical Device Development

November 4, 2019

Accelerate your medical devices’ embedded software development using cultural, process, and tool changes such as an embedded CI pipeline.

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