Who we help
Engineering support for counsel, manufacturers, and health systems.
Independent device analysis for legal teams, device makers, hospitals, and health systems, from the first technical assessment through expert testimony.
01Legal counsel
Understand the engineering behind the case.
We help plaintiff and defense counsel evaluate claims involving medical devices. Our work identifies the evidence that matters, tests the proposed causes of failure, and develops independent technical opinions.
Independent analysis from early case assessment through reports, deposition, and trial.
- Identify inspection priorities, key design records, and evidence gaps
- Reconstruct device behavior and evaluate causation theories
- Connect MAUDE reports and recall history with the incident evidence
02Manufacturers
Find the cause of a device complaint.
Device complaints can stem from design choices, software behavior, operating conditions, or a combination of factors. We review the records and test the equipment to identify the cause and evaluate possible corrective actions.
Focused testing and documented findings for engineering, quality, risk, and legal teams.
- Investigate performance complaints and disputed failures
- Review QMS records, the DHF, risk files, and requirements traceability
- Evaluate complaint and recall patterns alongside test evidence
03Hospitals & health systems
Establish the device’s role in an incident.
We help clinical engineering, risk management, and counsel understand what happened during a device-related incident. The review covers the equipment, settings, accessories, maintenance records, and recorded events.
An independent technical assessment to inform incident review, equipment decisions, and the response to a claim.
- Inspect equipment and review configuration and maintenance records
- Connect device logs, alarms, and operating conditions
- Identify evidence gaps and recommend further testing
Get in touch
Tell us about the device.
Share a brief overview of the device, the question you need answered, and any deadlines. We’ll explain how we can help and recommend the next steps.
info@alphadevices.io