There is some correlation between IEC 62304 and the FDA guidance document, but definitely use the FDA guidance document Karen listed as your primary source of information, structure, and content.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 13-Aug-2019 18:35
From: Karen Zhou
Subject: IEC 62304
IEC 62304 is the international standard required for software development. It's not mandatory for premarket submission, but it has the requirements of design control used to meet the quality regulations.
See also https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-premarket-submissions-software-contained-medical-devices
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Karen Zhou
Original Message:
Sent: 13-Aug-2019 06:18
From: Anonymous Member
Subject: IEC 62304
This message was posted by a user wishing to remain anonymous
Is compliance to IEC 62304 mandatory for 510K clearance of Class II medical devices containing software (firmware).
regards
Mike