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Domain · Technical Depth

For Software as a Medical Device, how do IEC 62304 and the FDA's premarket cybersecurity expectations shape how you build and maintain connected device software?

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IEC 62304 is the software lifecycle standard, and it's driven by a software safety classification — Class A, B, or C — based on the harm the software could cause if it fails.

The full answer: structure, worked example, likely follow-up.

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