FDA Software Guidances and the IEC 62304 Software Standard
There are two sets of rules for SW regulation—twice the rules, twice the confusion. My recommendation is to base your software development procedures on the IEC 62304 Standard and then include any additional adjustments needed to meet all the FDA requirements. This article details exactly what the IEC 62304 Standard entails.
One approach to satisfy two sets of rules
The Two Minds for Successful Product Development
This article by Roger Tang and Aaron Joseph explains the two mindsets need for successful product development process for innovative products.
Discover the two mindsets needed
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