News & Insights

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

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

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

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

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

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

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

MedTech Clinical Trial Readiness eBook Read more

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

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

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

Authored by: Beaufort Regulatory Team From MDUFA to EUDAMED—What Regulatory Leaders Need to Know The 2025 AMDM Annual In Vitro Diagnostics (IVD) Regulatory Meeting delivered two ... Read more