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Microscopy of Medical Devices

Intertek's microscopy teams deliver valuable information to process engineers and scientists involved in the design, production and testing of medical devices such as catheters, stents, coils, endoscopes, and other healthcare materials such as implants and disinfectants.

The microscopy teams have a long history in the fields of polymer science, materials characterization and microanalysis. Key factors in this success are the bringing of the micro-world of materials to life and the explanation of microstructure/ product-property relationships in terms of fundamental principles that help process-engineers improve the performance of the devices under their stewardship.

Intertek understands polymer science, adhesion and bonding, helping deformulate raw materials and understanding metallurgical processes such as fracture and corrosion.

Intertek's medical device production problem solving capability has led to significant improvements in client product yield, and our materials science consultancy has led to improvements in product design. As an independent party, Intertek is interested in the scientific facts. This focus allows our customers confidence in our ability to identify "at fault" raw material suppliers and the resolution of end user complaints.

Medical device microscopy requests: 

  • Deformulation of raw materials and assessment of raw material manufacturing processes
  • Adhesion and bonding investigations
  • Evaluation of moulded-in stresses and strains
  • Weld integrity issues such as surface contamination and weld homogeneity
  • Microstructure – product property relationships
  • End-user complaint investigation and validation
  • Failure analysis of polymers, coatings and metals
  • Product contamination and defect assessment
  • Polymer science consultancy

Medical device microscopy successes: 

  • Increased production yields (less rework/scrap)
  • Improved risk management through lower failure rates on product testing
  • Optimisation of raw materials through improved specifications
  • Development time reduced and re-validation prevented
  • Improved extrusion quality impacting on down-stream sub-assembly processes
  • Improvement of mechanical properties
  • Previously unknown regulatory issues identified
  • "At fault" suppliers (and customers) identified

 

to see how Intertek can help your organization with Microscopy of Medical Devices.