Start with the Process, Finish with the Work
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. […]
Medical Device Documentation
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. […]
IEC-62304 Medical Device Software – Software Life Cycle Processes Primer – Part II
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 […]
IEC-62304 Medical Device Software – Software Life Cycle Processes Primer – Part 1
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 […]
How much is that medical device going to cost!?!??!
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 […]