Medical Device materials failure analysis supports manufacturers of implantable medical devices and related healthcare products.

Intertek's material scientists are experienced in solving a wide range of material-related problems associated with the manufacture and operation of implantable medical devices, such as catheters and stents. Typical medical device material failure investigations include:

  • Root cause investigations associated with FDA incidents or patient fatalities (devices /catheters / stents / delivery mechanisms)
  • Cardiovascular (pre- and post-production) product contamination investigations
  • Manufacturing and supply chain auditing following gastro-pulmonary device production outages
  • In-process investigations aimed at improving neurovascular product manufacturing yields
  • Co-working with polymer raw material suppliers to improve quality input into final production materials

Analytical approaches to medical device problem-solving include:

  • Fracture and failure analysis of medical devices and associated materials
  • Surface chemistry and adhesion of product bonds
  • Microstructure and mechanical property relationships
  • Chemical imaging and phase distribution of actives
  • Materials deformulation and validation for QC

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