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Certified Pure Materials: 
Expedite FDA Approvals for Medical Devices

Tech Brief

Why download the tech brief:

In this tech brief written for medical device engineers and researchers, learn what third-party material purity tests are associated with each FDA application tier so that manufacturers can enable a faster device market launch.  The brief describes each of the relevant third-party tests and how you can determine the right level of purity needed for your type of medical device, along with what types of high-purity porous materials can be used.  Third-party testing includes leachables and extractables, as well as viral and bacterial filtration efficiency.

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