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
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 Read more
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Authored By: Beaufort Contributor On 27 November 2025, the European Commission published Commission Decision (EU) 2025/2371, formally confirming that the first four modules of EUDAMED—Actor Registration, ... Read more
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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 Contributor The AMDM IVD Focus Fall Meeting brought together regulators, industry leaders, and diagnostic professionals for two days of focused discussion and actionable ... 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 Contributor When the federal government shut down on October 1, 2025, the U.S. ... Read more
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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
BLOG
Authored by: Beaufort Contributor From MDUFA to EUDAMED—What Regulatory Leaders Need to Know The 2025 AMDM Annual In Vitro Diagnostics (IVD) Regulatory Meeting delivered two full ... Read more
ARTICLE
Updates to the UK Medical Device Regulations Authored by: Beaufort Contributor The regulatory landscape for medical devices, including in vitro diagnostics (IVDs), in the United Kingdom ... Read more
ANNOUNCEMENT
Strengthening our Commitment to Successful Client Outcomes Nilufer Celenk, Vice President, Clinical Program Management Beaufort is excited to welcome Nilufer Celenk, as Vice President of Clinical ... Read more
 
Blog

FDA’s Proposed Rule for LDTs and the impact on LDT manufacturers. … Read more

Article

AMDM IVD Focus Meeting highlights and key takeaways for IVD manufacturers … Read more

Blog

Navigating US Market Entry for Non-US Manufacturers … Read more

Article

Spectral Medical Inc. selects Beaufort for critical sepsis clinical trial … Read more

Blog

Eliminating Data Blind Spots with Clinical Monitoring Oversight. Q&A with SVP, Chief Quality Officer, John R. Wilson, Jr. … Read more

Article

IVDR Insights from Informa’s MedTech Summit 2023. Key Takeaways for IVD manufacturers … Read more

Article

Selecting the right CRO partner: Why IVD specialization is a game changer for sponsors. Key factors for sponsors to … Read more

Webinar

What data alone won’t tell you: The rising value of Clinical Monitoring Oversight. See how sponsors can protect … Read more