Operational Intelligence for Medical Device Operations
Accelerate service operations, calibration management, and device lifecycle intelligence with governed AI purpose-built for medtech compliance.
Key Pain Areas
Relevant Missions
Deviation Investigation Intelligence
Novulytix — a medtech & diagnostics manufacturer organized into three divisions (Cardia Rhythm Solutions, Pharma Manufacturing, Scientific Systems) — detects a seal-integrity deviation on Cardia Rhythm Solutions' Waukegan Line 4. The clock starts: initial assessment in 24 hours, full investigation on a committed timeline. The QA Manager must assemble evidence across batch records, environmental data, and equipment logs, identify root cause, and link a CAPA — while recurrence mapping reveals the same failure mode already closed on Line 2 on training-completion alone. Deviation Investigation turns a tribal-knowledge scramble into governed intelligence, with a human approving every step.
service opsEquipment Recovery Operations
A NovaSight LX-9000 shows progressive thermal instability during analytical runs at a research institute with an active FDA-regulated study. The service team scrambles across ServiceMax, SAP, service manuals, bulletins, Teams threads, and tribal knowledge to diagnose, escalate, and recover — while the clock runs on a 24-hour SLA and 48-hour sample viability window.