Rigorous NCR & complaint investigations
Reconstruct the timeline, find evidence gaps, work the root cause, and generate defensible CAPA options — with a readiness and quality score before sign-off.
Explore WorkbenchSolutions Medical Device
Medical DeviceAI copilots for medical device quality.
Make CAPA effective, investigate NCRs and complaints with rigor, and connect root cause analysis to risk — aligned with ISO 13485 and FDA QSR expectations.
CAPA
NCR & complaints
ISO 13485
21 CFR 820
Risk (ISO 14971)
The challenge
CAPA effectiveness is the recurring finding.
For device makers, ineffective CAPA and weak root cause analysis are among the most common inspection observations — and the hardest to fix at scale.
CAPAs that close without preventing recurrence
Shallow NCR & complaint investigations
Design vs process root cause confusion
ISO 13485 / 21 CFR 820 audit readiness
MDR / complaint trend exposure
RCA disconnected from risk management (ISO 14971)
The result: corrective actions that treat symptoms — not causes.
How we help
Three copilots, mapped to medical device.
Root cause depth that holds up
Coaches teams through structured A3 problem-solving so corrective actions target true root causes — building CAPA effectiveness into how people think.
Explore A3 CoachProcess improvement that sticks
Run focused Kaizen events on recurring nonconformances and yield issues, with 30/60/90-day sustainment plans to lock in the improvement.
Explore Kaizen Copilot
Regulated by default
Designed for the discipline ISO 13485 and FDA QSR demand.
Full audit trails, deterministic boundaries, and data security aligned with QSR (21 CFR 820) and 21 CFR Part 11 principles. The AI supports structure and evidence review — final corrective-action decisions and quality approval remain with your team.
Pricing
Start on a real CAPA backlog.
Start with sample or anonymized investigations and see the lift in root cause depth and CAPA quality in weeks.