|
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 offers medical device testing to solve non-routine problems. Our scientists have investigated difficult problems with a wide variety of materials and devices, including implantables, catheters, membranes, filters, coatings, sutures, dental materials, orthopedic prostheses, flexible tubing, containers and protective products.
We have special expertise in medical plastic testing. Our polymer experts have years of experience characterizing the composition of plastic materials, including determining the raw materials, resins and additives.
Our medical device testing services include:
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
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.
