IEC 62304 2nd Edition Draft for Review

The first committee draft of the second edition of “IEC 62304 Medical device software life cycle processes” has been circulated internally for comment. Major changes include a revision of how software safety class is determined, which could reduce the tendency towards most software being Class C; clear requirements for legacy software that explain how conformance can be established without full development conformance; and an informative process reference model. Comments are due by January 11, 2013.

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