News & Insights

Insights from the AMDM IVD Focus Meeting highlight opportunities to reassess regulatory pathways, leverage existing evidence and refine CDx development strategies. Authored by: Christine Scheve SVP, ... Read more

Beaufort, a MedTech contract research organization (CRO), today announced a series of executive appointments as the company enters its next stage of growth, strengthening leadership across ... Read more

Beaufort welcomes Christine Scheve as Senior Vice President, Chief Revenue Officer. With hands-on experience spanning research, product development, and regulatory strategy, Christine translates complex client needs ... Read more

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