Medical Device Failure Analysis Laboratories
Medical device failure analysis combines non-destructive examination, fractography, microscopy, chemical and materials analysis to find the root cause of a complaint or returned device. Results feed CAPA, complaint handling and, where applicable, regulatory reporting. Returned explants and devices may carry biological material, so decontamination and chain-of-custody arrangements must be agreed before shipping.
When is it used?
- Implant fracture or loosening
- Catheter, tubing or connector failure
- Coating delamination or particulate release
- Adhesive and bond failures
- Corrosion or polymer cracking
- Unknown residues or foreign material on devices
Sample considerations
- Agree decontamination and biohazard handling with the laboratory first.
- Preserve fracture surfaces; do not clean or reassemble parts.
- Include unfailed devices from the same lot.
Laboratories with relevant capabilities
No directory profile currently documents this specific capability. Submit a request and we will look for laboratories that cover it.