Medical Devices Industry

Medical Device Testing & Problem-Solving

   Why is this implant deteriorating?
      What are the components of this polymeric device?
        What is causing these contamination issues?

Chemir Analytical Services solves non-routine problems in the medical device industry, by offering contaminant identification, polymer analysis, deformulation (reverse engineering) and failure analysis. Our independent laboratory also offers litigation support for intellectual property or product liability issues.

We have years of experience providing investigative analytical services for the medical device industry. Our scientists have investigated difficult problems with a wide variety of materials and devices, including implantables, flexible tubing, containers and protective products.

Upon project completion, the Chemir final report includes data, interpretations and results. Our reports also include a detailed explanation of the test methods chosen, protocols, and traceability of the samples to the analysis. We are proud that our complete reports have played key roles in 510K submissions and other issues with the FDA.

Examples of problems solved for the medical device industry include:

Analyzed polymeric materials to evaluate products for resin composition
Identified a black flake contaminant in a device
Investigated a product failure of a polyurethane catheter
Deformulated a gas detection system in support of an intellectual property case
Performed polymer analysis to investigate biodegradation of an implanted device

Chemir’s services to the medical device industry include: