Medical Devices and Diagnostics: Post-Market Surveillance

Once the device is approved and in the market, devices post market continued support is required to evaluate quality issues, control manufacturing and manage supply chain. Unforeseen failures can occur during a products lifetime requiring companies to investigate and determine root cause.  Additionally, availability of critical raw materials for device manufacturing can change requiring new vendors of equivalent materials to be selected. EAG supports customers with failure analysis, raw material benchmarking and comparison, process improvement, and quality control testing of materials and components for devices post market.

Previously developed and validated methods can be used to continue quality control testing programs. EAG Laboratories has partnered with medical device and diagnostic companies to provide highly efficient and cost effective support in raw material quality control.

Medical device failure and performance concerns can occur once introduced to the market. EAG Laboratories has developed an investigative approach to failure analysis and we have expertise in the following materials:

Our investigative approach involves the expertise of the scientist or engineer combined with a full range of analytical capabilities to give the expert insight into the failure.

Process improvement is frequently pursued by medical device and diagnostic companies. During process improvement, batches of devices, materials or chemistries are generated with adjustments to the process.  EAG Laboratories has experience in supporting process improvement activities involving:

  • Method development/validation
  • Surface analysis and depth profiling
  • Microscopy down to nanometer scale features
  • Trace organic analysis
  • Polymer characterization
  • Metallurgical engineering
  • Elemental analysis

We recognize the importance of having a broad range of capabilities combined and have technical experts available for discussion.   Please call us at 800-366-3867 to speak with one of our scientists about devices post market study.

 

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