Blog
Read our latest blog on 8 Essentials for Managing Successful Medical Device and IVD Clinical Trials
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Blog
As published in Today’s Clinical Lab, read how FDA PCCP May Aid LDT Modifications
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Article
As medical devices, including IVDs, increasingly incorporate sophisticated software components, understanding and complying with FDA guidance on software documentation … Read more
Article
Navigating FDA’s Final Rule on LDTs. 6 strategies to help you meet FDA requirements and maintain market access
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Blog
Beaufort celebrates 20 years of growth and innovation — and helping clients advance human health through the rapid development and commercialization … Read more
Article
Regulatory readiness and preparedness during companion diagnostic development. Read key considerations to achieving contemporaneous drug and CDx authorizations
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