News & Insights

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

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.

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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
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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
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MedTech Clinical Trial Readiness eBook Read more
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Point-of-Care (POC) diagnostic trials for influenza are unlike any other. The season is short, virus circulation is unpredictable, and enrollment targets — particularly for influenza B ... Read more
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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
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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
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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
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Key Changes and Implications for Interventional Clinical Trials Authored by: Beaufort Contributor On January 6, 2025, the International Council for Harmonisation (ICH) officially released (adopted) the ... Read more
 
Announcement

Strengthening our Commitment to Successful Client Outcomes: Beaufort Appoints Nilufer Celenk as Vice President, Clinical Program Management. … Read more

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Advancing Innovation in Clinical Research: Beaufort provides Medrio with expertise and advisory support on launch of new AI-enabled reporting … Read more

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

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Beaufort Announces Appointment of Bill Trembley as SVP, Chief Technology Officer … Read more

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Beaufort is proud to have supported Virtual Incision in their successful U.S. FDA authorization … Read more

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Beaufort SVP selected as board president of the Association of Medical Diagnostics Manufacturers… Read more

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Moderna Receives Full U.S. FDA Approval for COVID-19 Vaccine SPIKEVAX. … Read more

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Beaufort is pleased to announce that it has joined Avoca Quality Consortium, a collaboration of … Read more