As a device manufacturer, you may need to change a material used in your medical device. When that happens, an update must be filed, which can result in a regulatory agency requesting additional information. Learn how Lubrizol’s commitment to quickly provide an OEM with supporting medical grade information for their device helped them avoid a delay in the regulatory filing process.
When conducting chemical and biological analysis of medical devices, your testing lab may need support to interpret the results of our medical-grade TPUs. Considering the large amount of extractable/leachable information that can be obtained, it’s important to properly understand the source of these substances. Learn how Lubrizol’s material expertise helped an OEM and its test lab with assessment of device-specific risk associated with TPU-specific extractable substances for their long-term implantable product.