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