IEC 62304:2006+AMD1:2015
IEC 62304 — Medical Device Software
Plain-language guides to IEC 62304:2006 + AMD1:2015 — the lifecycle standard for medical device software and SaMD.
IEC 62304:2006+AMD1:2015 — IEC Webstore ↗Free IEC 62304 Software Safety Classifier
Classify your software as Class A, B, or C in under 3 minutes — with mandatory document checklist.
Does IEC 62304 apply to my product?
For: All software teams
How do I classify software into Class A, B, or C?
For: Software engineers, RA
IEC 62304 Edition 2 — the actual status
For: Software teams, RA
What is SOUP and how do I manage it?
For: Developers, QA
Which documents are mandatory for Class A, B, C?
For: RA engineers, QA managers
How does Agile/Scrum work with IEC 62304?
For: Software teams, project managers
How do I build a traceability matrix?
For: QA engineers, RA
How are IEC 62304 and ISO 14971 related?
For: RA engineers, safety engineers
How do I document changes and bug fixes?
For: Developers, QA
What does an auditor check for IEC 62304?
For: QA managers, RA
Unit, integration, and system tests — what is expected?
For: Software engineers, QA