Design Verification Traceability Agent

Medical device design controls require every requirement to be traced to verification evidence, and gaps found by an auditor can delay a launch. Each week this agent reads the requirements list, test protocols and test reports and builds the trace matrix. It checks that every requirement has a test, that the test covers the current requirement version, and that the report shows a pass with the right sample size. Gaps are listed with owners, and the agent checks again after they are fixed. When requirements change, it flags tests that may no longer cover them. The engineer approves the matrix before it goes into the design history file. Edge case: a test that passed on an earlier prototype is flagged if the design has changed since, so old evidence is not reused by mistake.