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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…
Read MorePart 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…
Read MoreIEC-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…
Read MoreCreating 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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