News & Insights

An expert holding a microphone gives a talk about in vitro diagnostic clinical trials to an interested audience.
 
All News & Insights

Our industry is constantly evolving, from in vitro diagnostic (IVD) advances and New regulatory requirements to Emerging Technologies and clinical trial best practices. Get an expert perspective from Beaufort.

 
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 … Read more

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 … Read more

Event

Visit Beaufort in Booth # 4739 at the ADLM 2024 Annual Meeting in Chicago (July 30 – Aug 1). Set a meeting with our experts.… Read more

Event

Beaufort will be presenting “Exploring the CDx Landscape” at the 17th Annual IVD Clinical and Regulatory Affair … Read more

Blog

FDA Letter to Industry Calls on Device Sponsors to Independently Verify Third-Party Data … Read more

Event

Visit our team during AMDM’s 50th Annual IVD Regulatory Meeting & FDA IVD Submission Workshop from April 22-25, 2024.… Read more