Medical Device Development

Start with the Process, Finish with the Work

By Joe Schneider / 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

By Joe Schneider / 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

By Joe Schneider / 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

By Joe Schneider / 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

By Joe Schneider / 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!?!??!

By Joe Schneider / 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

By Ryan Arnholt / November 4, 2019 / Comments Off on Accelerating Medical Device Development

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

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