IEC 62304 - A thorough yet simple guide

Building and releasing medical device software is hard, very hard. Here at Extra Horizon we have had a lot of experience in successfully building, launching and scaling Medtech products that are IEC 62304 compliant.

We often get lots of questions regarding the IEC 62304 standard, as it is not the easiest of standards to follow.

There are a lot of concepts and terms that you need to familiarise yourself with, which can often seem quite daunting.

That’s why we took it upon ourselves to write an elaborate guide on IEC 62304 with the main purpose of navigating the reader through the most important concepts of the standard.