Medical Device Development

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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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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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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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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