Medical Device Problem Solving

Medical device materials failure investigation and problem solving.

Intertek experts work on materials analysis failure investigation projects for invasive medical devices, including cathers and stents. Experienced scientists work with clients for root-cause analysis and remediation in the production environment.

Medical Device trouble-shooting analysis methods include:

• FDA incidents and patient fatalities (devices/catheters/stents/delivery mechanism) root cause investigations
• Cardiovascular (pre + pst production) product contamination investigations
• Manufacturing and supply chain auditing following gastro-pulmonary devide 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.