Capabilities

Testing, analysis, and expert testimony.

We examine how a device was intended to work, how it actually behaved, and what its records reveal. Each investigation draws on the testing and analysis needed to answer the specific question.

01Engineering investigation

Failure analysis & reconstruction

We inspect the device and its components, reconstruct the relevant operating conditions, and test each proposed cause of failure. The investigation gives equal weight to evidence that the device operated normally.

What you receive

A documented assessment of the failure mechanisms, the alternative explanations, and the limits of the available evidence.

Mechanical, electrical, thermal, and fluid-system analysis
Device condition, accessories, and maintenance history
Incident reconstruction and comparative evaluation
Assessment of both malfunction and normal operation

02Engineering investigation

Custom testing & measurement

We build test fixtures, instrument sample devices, and recreate the operating conditions that matter. The measurements show whether a proposed failure mechanism is consistent with how the device actually performs.

What you receive

A focused test program with recorded methods, measurements, results, and limitations.

Custom fixtures and instrumented test environments
Sample-device and comparative testing
Pressure, flow, temperature, and particle measurements
Repeatable experiments built around the technical question

03Engineering investigation

Software, firmware & device data

We analyze code, firmware, settings, and recorded signals alongside the physical evidence. That lets us reconstruct the sequence of events and explain how the device’s sensors, alarms, and controls responded.

What you receive

A documented account of system behavior and event timing, with missing or conflicting information identified.

Code and firmware evaluation
Event logs, waveforms, and time alignment
Alarm, sensor, and control-logic analysis
Correlation of recorded events with bench testing

04Documentation review

Design & quality documentation

The technical record shows how a device was designed, which risks were recognized, and how the safeguards were tested. We trace those decisions through the design and quality documentation, identify gaps, and evaluate whether the evidence supports the conclusions in the file.

What you receive

An assessment of design decisions and risk controls against test results and field experience, with supporting records and open questions identified.

Verification and validation protocols, results, and deviations
Complaint investigations and corrective and preventive action (CAPA)
Warnings, instructions, design changes, and foreseeable use
Analysis against the standards and requirements that applied at the time

Standards & regulatory analysis

Inside the technical record

Quality management system (QMS): Procedures, quality records, complaints, audits, and CAPA: how an issue was identified, investigated, and addressed.
Design history file (DHF): Design inputs, outputs, reviews, and changes: how the device evolved and what evidence supported each decision.
Risk analysis and risk-management files: Identified hazards, estimated risks, controls, and residual-risk evaluations: whether the failure mechanism was anticipated and addressed.
Traceability matrices: Requirements, risk controls, and verification and validation results: whether the documentation shows that each requirement was tested.

05FDA data research

MAUDE & FDA database analysis

We analyze MAUDE and the other openFDA datasets to find related reports and trace a device’s regulatory history. Records are matched by product name, manufacturer, model, and device identifier so the incident can be seen in context.

What you receive

A history of relevant reports and regulatory events, supported by source records, search criteria, and a clear statement of the data’s limitations.

Targeted searches by device, manufacturer, product code, and event type
Review of event narratives, report patterns, and relevant dates
Cross-checking related records and identifying potential duplicates
Comparison with device testing, complaints, and design records

MAUDE reports help identify questions for investigation. On their own they do not establish causation or failure rates. We account for reporting limitations and incomplete or unverified records when interpreting the findings.

Datasets we analyze · openFDA

MAUDE adverse-event reports: Reported malfunctions, injuries, and deaths; event narratives and related reports.
Medical device recalls: Recall reasons, affected products, and the corrective actions described in the records.
Recall enforcement reports: Published recall classifications, affected lots, and distribution details.
510(k) clearances: Device submissions, applicants, and clearance decisions that establish the regulatory timeline.
Premarket approval (PMA): Approval applications, supplements, and decision dates for the device under review.
Device classification: Product codes, device classes, and specialty categories that define relevant comparisons.
Establishment registrations & device listings: Manufacturer and establishment records that connect firms with their listed devices.
Unique device identification (GUDID): Device identifiers, brand names, and model information used to match products across records.

06Engineering investigation

Expert reports & testimony

We develop independent technical opinions and evaluate opposing explanations. Our reports and testimony set out the findings, the methods behind them, and the evidence supporting each conclusion.

What you receive

Clear expert reports, technical demonstratives, and testimony grounded in the investigation.