IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 5: software development process – IEC 62304:2015 Medical Device Software Lifecycle Processes

IEC 62304:2015 Medical Device Software Lifecycle Processes 5.7.4: 5.7.4 Evaluate software system testing

The manufacturer confirms that: the verification strategies and test procedures are suitable; system test procedures can be traced back to the software requirements; every software requirement has been tested or verified in some other way; the links between requirements and tests are recorded; and the test results satisfy the pass or fail criteria. Applies to classes A, B and C.

Maintained by Gerard BlokdykControl text last updated

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  • 7.7 Overall software testing / Final validation

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Other controls in Clause 5: software development process – IEC 62304:2015 Medical Device Software Lifecycle Processes

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