The Importance of IEC 62304 Compliance Part 2

Following up on our first blog post on how to become a trusted software supplier to established medical device manufacturers with the help of IEC 62304, we will now shed some light on specific clauses and requirements of that standard. IEC 62304:2006/Amd 1:2015, 4.3 – Software Safety Classification The 2015 amendment provides more clarity on […]