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 […]

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The Importance of IEC 62304 Compliance

IEC 62304 outlines the guiding principles for the development of medical software. It is the gold standards for medical device companies, but its importance goes beyond legal manufacturers and established medical software suppliers. In the vast majority of cases, software embedded in a device (or a device itself) use abundant OTS (Off The Shelf) code, […]

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