Agree with Richard, with a couple of caveats (referencing 62304:2006 +AMD1:2015):
- There is no mandate in 62304 for unit "testing". There is a mandate for unit "verification". In section 5.5.2, the standard seems to allow multiple means of unit verification (e.g. code review, static code analysis, unit testing), but if unit testing is chosen as the means for unit verification, then those "procedures shall be evaluated for adequacy" and would be executed using similar requirements for testing found elsewhere in the standard.
- Although not advisable, the "Note" immediately after the text I referenced above states that it is permissible to combine integration testing and software system testing. This does not mean that integration testing is circumvented. It means that both activities can be consolidated, so it would be important to show in the procedures which are system tests and which are integration tests. This language is repeated in the "Integration Testing" section in Note 2 below 5.6.4.
In my personal experience, regulators have found the overall test effort to lack some credibility if all of the defects are reported and fixed during system testing. As a practical matter, the ability to find and fix more issues more quickly and less expensively rests, to a large extent, in the earlier phases of the development lifecycle through debugging activities, peer reviews, and unit verification activities.
Trying to circumvent these steps, in my view, will reduce your ability to address issues closer to the point of insertion, when they are easier to find, less expensive to fix, and less impactful on other connected parts of the system. It is also likely that much of this work is going on in an "informal" way, and the real debate is how much to document them, which brings up our old regulatory mantra, "If it isn't documented, it never happened."
I hope this helps
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Eric Henry
Washington DC
United States
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Original Message:
Sent: 19-Feb-2019 23:13
From: Anonymous Member
Subject: IEC 62304 Unit Testing and Integration Testing
This message was posted by a user wishing to remain anonymous
In developing a Class B software medical device (e.g. a mobile app), can a company ever justify not completing unit and integration testing and jump straight to system testing? Thanks!