Intertek (www.intertek.com)
 

Medical Device Materials Failure Analysis

Industries serviced: Medical & Pharmaceutical

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Intertek QTI

P.O. Box 470
291 Route 22 East
Salem Industrial Park
Whitehouse, NJ 08888
USA

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
Related Medical Device Services:

to see how Intertek can help your organization with Medical Device Materials Failure Analysis.

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