ISO 14971 risk analysis from your device master record. QMSR is live. Your FMEA is the evidence.
DFMEA generated from design inputs, specifications, and predicate device data per 21 CFR 820.30. Hazard analysis aligned with ISO 14971 severity and probability scales. Design outputs linked to risk controls.
Process FMEAs from IQ/OQ/PQ protocols and manufacturing process flows. Control plans auto-linked to PFMEA rows. Critical process parameters traced to design risk controls.
Structured risk management output aligned with ISO 14971. Hazard identification, risk estimation, risk evaluation, and risk control measures. Overall residual risk assessment included. Ready for your management review.
Post-market surveillance data and complaint records matched against existing risk analysis. New hazardous situations flagged. Risk-benefit analysis updated. 21 CFR 820.198 complaint handling linked to risk files.
CAPAs matched against root cause in the risk file. Corrective actions linked to specific failure modes. Effectiveness verification tracked. Risk scores updated when controls change.
Deployed on your AWS/Azure tenant. Zero data egress. SOC 2 controls. Air-gapped mode available. Your device master records and complaint data never leave your environment.
Search across design history files, predicate device data, standards, and risk management files in conversation. Ask questions, get cited answers. Works in 34 languages, online or air-gapped.
For software-as-a-medical-device and software components: SFMEA aligned with IEC 62304 software safety classes. Failure modes for software units, integration, and system-level hazards.
Risk management aligned with EU MDR Annex I general safety and performance requirements. Clinical evaluation linkage. Post-market clinical follow-up integration with risk analysis updates.
Medical device manufacturers under FDA QMSR, ISO 13485, or EU MDR with design control requirements, post-market surveillance obligations, and risk management files that need to stay current across the product lifecycle.
Generate DFMEA from design inputs and predicate device data. Build the risk management file as the design evolves. Risk controls linked to verification and validation activities.
Import existing risk files. Enrich with complaint data, field actions, and CAPA records. Regenerate reasoning your team never documented. Keep the risk management file current as post-market data accumulates.
Each phase has a deliverable and a go/no-go gate. We earn the next one.
Weeks 1-3
1 device or product family. Draft risk analysis. Hazard identification. Source traceability.
Gate
70-90% of rows pass engineer review → expand
Months 2-4
Roll out to additional device families or product lines. Integrate with complaint handling and CAPA workflows.
Gate
Risk management files meeting regulatory review standards across device portfolio?
Months 5-12
Living risk management: post-market data updates risk files automatically. Audit-ready documentation. Cross-portfolio intelligence.
Gate
Renew and expand to additional product lines or sites.
Bring one manual. We show you what yours missed. 30 minutes.
