Turn "No Fault Found" returns into objective regulatory data. Forensic root cause analysis to permanently close CAPAs and protect hardware margins.
Chronic field failures and 'No Fault Found' returns drain hardware margins and expose you to ISO 14971 compliance risks during Post-Market Surveillance. Guessing the root cause is not a defensible QMS strategy.
We transition your subjective field complaints into objective, physics-based evidence. We isolate the failure mode and provide the engineering data required to formally close an ISO 13485 Clause 8.5 CAPA.
Extraction of raw telemetry, capture of external physical states, thermal imprints, and execution of IEC 62353 electrical baselines.
Comparative disassembly against a Known Good Unit (KGU) to capture break-torque metrics, seal integrity, and isolation barrier deviations.
Application of the 5-Whys methodology to definitively classify the fault as Design (DfM/DfS), Manufacturing, Use-Error, or Service execution.
Re-commissioning of the failed asset to a safe state, followed by translation of metrology data into a regulatory-grade report, including strict Verification of Effectiveness (VoE) metrics.
Contaminated Evidence. The client must provide a Decontamination Certificate strictly limiting cleaning to a surface wipe. We will immediately reject units subjected to deep internal cleaning, fluid flushing, or depot-level "tinkering" prior to handover, as this destroys vital forensic evidence.
Deployed as either a targeted project response or an ongoing sustaining retainer.
End-to-end 6-Phase FRA Execution for up to 3 Failed units + 1 KGU baseline. Capped at a maximum of 5 days of forensic analysis.
Additional forensic analysis days (if authorised) due to complex intermittent faults or missing client data.
Guarantees 2 days per month of priority engineering support for R&D technical triage and QMS review. (Min 3-month term).