Software as a medical product has become a widespread approach, both as part of an embedded device and as a standalone application. This article outlines how to address risk in your design process through software best practices IEC 62304.
Read MoreMedical device regulations require information to be recorded as you develop; this includes how the design was created, why design decisions were made, and what risks were considered in the process. Here is a basic outline to get you started.
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