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.

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.