In traditional medical engineering, requirements change weekly while test protocols gather dust for months. The result is the "Green Dashboard Illusion": test suites execute with 100% pass rates, but they test obsolete specifications that collapse under regulatory inspection. PMX Verification Intelligence binds every requirement directly to its executable protocol and raw cryptographic telemetry hash.
Why modern fast-paced medical engineering teams unknowingly ship devices with invalid verification records.
A Jenkins or GitHub Actions CI pipeline reports 1,420 tests passing. But an audit reveals that 320 of those tests assert against Rev 1.2 requirements. The requirement was modified in Rev 2.0 to lower temperature limits from 43°C to 41°C, yet the automated test script was never updated.
Engineers write code or add hardware features that were never formalized in a Design Input Requirement. Conversely, critical risk mitigations in the FMEA have no corresponding test protocol at all. These "phantom tests" and "blind requirements" lead directly to FDA 483 inspection observations.
When an FDA inspector asks: "Show me the raw temperature sensor logs from the chamber test conducted on March 14th," engineering teams scramble to find an un-hashed CSV file on an uncalibrated laptop. Under 21 CFR Part 11, unverified raw data is legally non-existent.
Mathematical proof propagating from design inputs through raw test chamber instrumentation directly to regulatory submission chapters.
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Inspection of live verification metrics and active thermal stress test run V-0183.
Derived from REQ-0184 • Verified against IEC 60601-1-11 Clause 11.1.2.2
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