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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
 
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

Blog

At-Home, POC, DCTs & Hybrid Models: IVD Expertise Across Every Use Setting … Read more

Blog

Regulatory Insights to Meet Evolving IVD QMS Requirements: LDTs, IVDR, & QSR to ISO 13485:2016 … Read more

Article

Unlocking Technology:  The Advantages of a Tech-Savvy CRO for IVD and Device Trials … Read more