Defensible Investigations for Medical Device Quality Teams
When your investigation has to satisfy an auditor, a customer, and your own engineering team, you need more than a spreadsheet and a fishbone diagram.
The Cost of Traditional Investigations
The Problem
- Pressure to be both technically rigorous and regulatory-defensible.
- Engineers must reconstruct events across design, manufacturing, suppliers, and field data.
- Investigations happen under intense time pressure from shipment holds or customer escalations.
The Impact
- Teams use document management tools instead of causal analysis platforms.
- Evidence is scattered across QMS, Slack, Jira, and shared drives.
- Connecting disparate data into a coherent narrative takes weeks and leaves gaps.
Lattice Root Cause
- Unifies all evidence into a single workspace.
- Agentic AI traces causal interactions automatically.
- Generates defensible investigation reports instantly without cutting corners.
48% of FDA Warning Letters cite inadequate root cause investigation.
We analyzed 417 FDA warning letters issued to medical device and pharmaceutical manufacturers between 2022 and 2025. Nearly half specifically cited failures in CAPA and root cause investigation. Lattice helps you build an audit-ready, defensible investigation engine that scales.
Read the full RCA research report →Core Investigations
Systems designed to handle the highest stakes in the medical devices industry.
CAPA Root Cause Investigations
Systematic causal analysis for corrective and preventive actions triggered by complaints, deviations, or audit findings.
Complaint & Field Failure Investigations
Determine whether field failures trace to design, manufacturing process, materials, or usage conditions.
Nonconformance Investigations
Investigate production deviations, out-of-spec results, and process excursions with full evidence traceability.
Supplier Quality Investigations
Investigate incoming material defects and manage supplier corrective action requests (SCARs) with linked evidence from supplier and internal data.
Design-Related Failure Analysis
Investigate whether product failures are rooted in design decisions, and connect investigation findings to design history.
Post-Market Surveillance Investigations
Correlate field data patterns with manufacturing batch history to identify systemic quality signals.
Start with an investigation
your team can explore.
Begin with a tailored dataset and engineer's guide, or bring a closed case your team knows well. See how Lattice builds the evidence trail before deciding whether to use your own live data.