<h1 class="entry-title">Category: Software</h1>

Are DoC Updates Required for Software Version Changes?

January 22, 2024   Are DoC Updates Required for Software Version Changes?   In general, yes.  I explain:   Remember that the MDR requires the manufacturer to “continuously update the EU declaration of conformity”.  For example, if the Technical Documentation (TD) is different for version 3.0 compared to 3.1 to 3.1.1 to 3.2, then the […]