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Considerations for Sponsors Navigating a Shifting Landscape Read more
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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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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
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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