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 5.6.7: 5.6.7 Integration test record contents

The integration test record documents the result (pass or fail with a list of anomalies), retains enough to repeat the test (test case specifications with actions and expected results, equipment, test environment including tools), and identifies the tester. Applies to classes B and C.

Maintained by Gerard BlokdykControl text last updated

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

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.