Edition 1 · IEC 62304:2006+AMD1:2015

IEC 62304 Essentials

The international standard for medical device software development lifecycle processes. Build your regulatory knowledge with structured learning and timed assessments.

Covers Edition 1 of the standard — IEC 62304:2006 together with Amendment 1:2015, the version currently in force. The consolidated text carries the designation Edition 1.1. Edition 2 is in development and is not covered here.

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Clause 4 → Clause 9, one continuous lifecycle

13 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).

How to use this course

Work through the Learn section to understand each lifecycle process area. Mark phases as studied to track your progress, then test your knowledge in the Quiz section.