Resources

Practical guides for medical device litigation.

What to preserve, which records to request, and how to examine the evidence, written from the engineering perspective. Read online or download a copy for the case file.

Practical guides Company materials

Practical guides

A useful place to start.

01 · Evidence preservation
A device failed. What happens next?
Preserve the device, capture its data, and establish a clear record before testing or return to the manufacturer.
1-page checklist · PDF
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02 · FDA data
Searching MAUDE with purpose
Build a reproducible search, read the underlying reports, and separate useful leads from unsupported conclusions.
2-page guide · PDF
Read Download Search MAUDE with BioGrid
03 · Design documentation
Understanding waterfall design
Trace a device from user needs through requirements, design, and testing, and understand what verification and validation each establish.
2-page guide · PDF
Read Download