At a glance
- Short name
- ISO 62304
- Jurisdiction
- US
- Also known as / related labels
- ISO 62304:2006+AMD1:2015 · ISO 14971 · IEC 62366 · FDA Software Guidance
What this entry covers
Evaluate medical device software development per ISO 62304:2006/AMD1:2015, covering software safety classification, development processes, risk management, and maintenance
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Official documentation
- Primary official source: https://www.iso.org/standard/38421.html
How to use this index entry
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