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 […]