Professional Development
IEC 62304 Essentials
The international standard for medical device software development lifecycle processes. Build your regulatory knowledge with structured learning and timed assessments.
12
Process Areas
3
Safety Classes
15
Quiz Questions
What is IEC 62304?
IEC 62304 is the international standard defining life cycle requirements for medical device software. It specifies processes for development, maintenance, and risk management of software embedded in or used as a medical device.
Who needs to know it?
Software developers, quality engineers, regulatory affairs specialists, and project managers working on medical device software in any jurisdiction that accepts IEC 62304, including the EU (MDR/IVDR) and US (FDA).