IEC 62304 does not cover which of the following?

Validation and final release of the medical device, even when the medical device consists entirely of software.
Development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device.
Life cycle requirements for medical device software.
Covers all of the Choices.
Verified Answer
Correct Option - a

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Updated on Fri, 7 Nov 2025