FDA· Jun 18, 2026
SPDF and IEC 62304 Mapping: FDA Cyber
How SPDF activities map to IEC 62304 software lifecycle processes - the exact crosswalk FDA reviewers expect, where they overlap, and where 62304 falls short.
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Showing 2 of 2 articles tagged Software Lifecycle
Compliance· Jun 12, 2026
IEC 62304 Classes vs FDA Device Classes
IEC 62304 software safety classes (A/B/C) and FDA device classes (I/II/III) are not equivalent. See how each one drives cybersecurity evidence under Section 524B and the Feb 3, 2026 guidance.
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