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Medical Device Materials
Medical device materials include a broad cross-section of substances present in a therapeutic or diagnostic medical device. These materials may provide structural support or mechanical assistance. They can also be used for drug storage or as the vehicle by which a therapy is administered. Depending on the use of the device, the medical device materials may require intense investigation such as an extractables and leachables study or ISO 10993 chemical characterization testing before use in humans.
Medical Device Material Expertise at EKG Labs
EKG Labs has worked with many types of medical devices that incorporate components made of diverse materials. It is important to understand if these materials might have a negative impact on human health, especially if they are implants or deliver a therapy that comes into contact with the body. At EKG Labs, we use diverse analytical techniques to analyze medical device material and to determine if any impurities or degradants need to be investigated by a toxicologist.
Material Expertise
- Polymers including plastic, rubber, resins, elastomer, swellable polymers, nylons, and natural products
- Bioabsorbables
- Metals and alloys
- Ceramics
- Composites
Device Expertise
- Drug-eluting stents
- Ophthalmic lenses and implants
- Dental implants and adhesives
- Metered dose inhalers, nebulizers, and other novel inhalation technology
- Wound-healing devices
- Filler devices
- Pumps and other drug delivery devices
- Cardiovascular devices
- Pulmonary devices
- Various drug/device combination products
Testing Expertise
Analytical Techniques
- Chromatographic Characterization – HPLC, LC/MS, GC/MS, GC/FID, GC/TCD, GPC, GPC/SEC
- Spectroscopy Characterization – ICP-MS, NMR, MS, PXRD, TF-XRD, UV-Vis, FTIR, Raman
- Microscopy – SEM, TEM, AFM, STM, LSCM
- Other- TGA, DSC, TOC, BET Surface Area/Pore Size Analyzer
- Learn more about our instrumentation here
