Clinical and medical device software validation
We build validated software testing programs for healthcare organizations where test evidence is a regulatory obligation under FDA 21 CFR Part 11 or ISO 13485 — not an internal quality record. Validation frameworks produce IQ, OQ, and PQ documentation as structured pipeline outputs, with full traceability between requirements, test cases, and execution results. For EHR integration and clinical decision support platforms, we validate against patient safety workflows with zero tolerance for post-deployment regression.










