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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.

ANNOUNCEMENT
Beaufort welcomes Christine Scheve as Senior Vice President, Chief Revenue Officer. With hands-on experience spanning research, product development, and regulatory strategy, Christine translates complex client needs ... Read more
ANNOUNCEMENT
Beaufort announces the retirement of Schuyler Ritter, Co-Founder, EVP and Chief Commercial Officer, after 22 years of leadership. Schuyler co-founded Beaufort with a vision to build ... Read more
ARTICLE
Success depends on more than conducting an effective IVD clinical trial program or even securing a favorable regulatory determination. It requires building an evidence-generation strategy that ... Read more
ARTICLE
Introduction Since application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) in May 2022, CDx manufacturers, medicine sponsors, notified bodies, national competent authorities ... Read more
ARTICLE
Considerations for Sponsors Navigating a Shifting Landscape Authored by: Bill Trembley Senior Vice President, Chief Technology Officer AI is Already Inside the Building Every clinical research ... Read more
ARTICLE
Authored By: Beaufort Regulatory Team On 27 November 2025, the European Commission published Commission Decision (EU) 2025/2371, formally confirming that the first four modules of EUDAMED—Actor ... Read more
ARTICLE
EU and U.S. Regulatory Considerations for Post-Market Advertising and Promotion of IVDs Authorized in vitro diagnostic medical device (IVD) claims must be supported by a defined ... Read more
BLOG
Authored by: Beaufort Regulatory Team The AMDM IVD Focus Fall Meeting brought together regulators, industry leaders, and diagnostic professionals for two days of focused discussion and ... Read more
ARTICLE
MedTech Clinical Trial Readiness eBook Read more
BLOG
Point-of-Care (POC) diagnostic trials for influenza are unlike any other — and within Beaufort’s infectious disease CRO services, they represent some of the most operationally demanding ... Read more
ARTICLE
What It Means for FDA Operations and the Diagnostics Industry Authored by: Beaufort Regulatory Team When the federal government shut down on October 1, 2025, the ... Read more
ARTICLE
Insights from the IVD Track at MedTech Summit 2025 The IVD track at MedTech Summit 2025 in Berlin brought together regulators, notified bodies, and industry experts ... Read more
 
Event

Beaufort is pleased to sponsor AMDM’s Fall IVD Focus Meeting. Come meet our team from Oct 17-18 in … Read more

Announcement

Beaufort announces two strategic additions to its leadership team that align with its commitment to operational excellence and innovation… Read more

Blog

As published in Today’s Clinical Lab, read how FDA PCCP May Aid LDT Modifications … Read more

Webinar

Discover essential strategies for navigating IVDR compliance and enhancing clinical trial success when developing companion diagnostics in the EU.… Read more

Event

On Aug 20, Beaufort is presenting “Clinical Trials with CDx—Navigating the Complexity of the IVDR” at the … Read more

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