Medical Device Failure Analysis

Medical Device Manufacturing Support

SEM Lab, Inc. has extensive experience in doing detailed and comprehensive materials and failure analysis on medical devices such as tools, catheters and stents.  When these devices fail it is important to accurately determine the cause in order to avoid any future problems.  SEM Lab, Inc. provides medical device failure analysis and manufacturing support. 

Medical Devices

Manufacturing and Operations


SEM Lab, Inc. is experienced in analyzing a large number of material and device related problems associated with the manufacture and utilization of medical devices. 

 

Examples

Catheters, Stents, Medical tools, etc.


  • microsection of imaging catheter ultrasound array assembly
  • failure analysis of a fractured catheter
  • fracture surface analysis of nitinol wire stents
  • identification of capacitor dielectric material
  • identification of residues under BGA
  • failure analysis of programmable logic device
  • pressure sensor failure analysis
  • failure analysis during product development phase

Evaluation of QFN heat sink soldering quality.

Evaluation of QFN heat sink soldering quality.

Identification of solder fill issue on thru-hole solder joints.

Identification of solder fill issue on thru-hole solder joints..

Evaluation of CSP solder joint quality.

Evaluation of CSP solder joint quality.

Corrosion on a contact shows chemical and fretting processes.

Corrosion on a contact shows chemical and fretting processes.

Fracture initiation at Ti-rich inclusion in Nitinol device.

Fracture initiation at Ti-rich inclusion in Nitinol device.