Medical Device Failure Analysis
The scientists at Chemir Analytical Services have been investigating and resolving medical device product failures for many years. This experience allows us to recognize indicators of failure and follow these leads to their root cause. We will help you define the problem and recommend solutions.
A medical device product failure may include premature breakage, degradation or chemical changes.
The types of materials tested in medical device failure investigations have included:
- Plastics
- Adhesives
- Metals
- Coatings
- Composites
- Laminates
- And more...
Our in-house laboratory includes a variety of instrumentation for failure analysis such as optical microscopy, SEM/EDXA, FT-IR, DSC, TGA, TMA, GC/MS, LC/MS and GPC. We also provide physical failure analysis through tension, compression, 3 point bending and permeability, as well as surface analysis and metallography.
To better understand the problem, we may recreate the failure conditions. Both customized analyses and application of established standards such as ASTM methods are employed.
Chemir's final report includes conclusions, results and all the original technical data acquired during the analysis including photographs, chromatograms and spectra. Finally, recommendations for prevention of future medical device failures are presented and, if necessary, our experts are experienced in providing litigation support.