Solving Regulatory Challenges in Medical Device Development

As formulators of medical-grade materials, Lubrizol’s team of product, regulatory and technical experts pride themselves on being proactive and readily available to help medical device OEMs navigate through the complex and challenging regulatory landscape and material selection needs as they arise. Below are just a couple of our success stories.

Quick Action Avoids a Regulatory Update Delay

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. 

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People in lab

Material Expertise Accelerates Device Biological Risk Assessment

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. 

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