Failure Analysis of medical products requires the use of unique mechanical and analytical techniques. The final goal of a product failure analysis is the determination of the mode and cause of failure. The first step is to perform a thorough inspection on the failed part, initially with an optical stereomicroscope and subsequently with a scanning electron microscope. Mechanical testing provides the tensile, dynamic, impact, thermal and stiffness properties of the material(s). While procedures vary, the primary mechanical tests provide a comparison between measured data to a specification, or to data generated by a known benchmark. Computer-aided stress analysis can provide the stress distribution of the part in service, with the results detailing the geometrical effect of the failure.

Testing that may be Performed During Failure Analysis Includes:
Chemical Testing
Compound Analysis
Fatigue Testing
Finite Element Analysis (Computer-aided Stress Analysis)
Formula Reconstruction
Impact Testing
Mechanical/Physical Testing
Microscopic Analysis
Ultra High Strain Rate