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.

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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
 
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Our Chief Technology Officer highlights key considerations for sponsors developing and operationalizing AI governance frameworks in clinical research. … Read more

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The European Commission has confirmed full functionality of EUDAMED’s first four modules, with mandatory use beginning 28 May 2026. What … Read more

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Understanding EU and U.S. regulatory considerations for post-market advertising and promotion of IVDs is essential to remain in … Read more

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AMDM IVD Fall Focus Meeting 2025: From Policy to Practice in Diagnostic Regulation. As global diagnostic regulation continues to advance, … Read more

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To help you better navigate MedTech trials, our experts developed the MedTech Clinical Trial Readiness eBook. … Read more

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Government Shutdown 2025: What It Means for FDA Operations and the Diagnostics Industry … Read more

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Your Strategic Roadmap for Successful Seasonal Influenza IVD Clinical Trials. Every week counts, and missteps in site startup, patient … Read more

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IVD Insights from MedTech Summit: Turning Regulatory Complexity into Strategic Advantage … Read more