New Eurofins Consulting Insights turns scientific evidence into clear regulatory success with end-to end client solutions

Craig Hopson, Senior Director of Medical Device Services, Consulting, Eurofins Medical Device Services

Eurofins Medical Device Services has launched Consulting Insights, establishing a new consulting division and signaling the company’s clear intent to deliver end-to-end client solutions. Consulting Insights, a division of Eurofins Medical Device Services, is designed to translate scientific evidence into actionable regulatory insight. We connect non-clinical data development with practical regulatory
guidance, moving your team across the medical device development lifecycle.
Clients are already seeing the difference in core deliverables.

Toxicological Risk Assessments arrive with transparent rationales tied to materials, use conditions, and clinical context. Biological Evaluation Plans are sized to actual risk and map directly to extraction and analytical work, making testing purposeful – not generic. Biological Evaluation Reports link study results and literature into
conclusions that are easy to navigate and difficult to dispute. Together, these documents read as a single narrative and often reduce the number of clarification rounds, which saves time and preserves budgets.

Eurofins’ approach begins at inception. Our consultants create data development plans to align testing requirements with regulatory strategy. Whether guiding FDA engagement via Q-Submission or supporting your premarket submission, our regulatory experts and scientists work in lockstep to produce integrated, reliable, and actionable data.

People and technology make this scalable. This new business unit for Medical Device Services is led by me; I bring 20+ years building high performing consulting organizations. Our dedicated Regulatory Intelligence team, led by Hal Stowe, tracks emerging guidance and reviewer trends and translates them into practical insights for clients and for our service design. Consulting operations strategy, led by Ashley Harger, focuses on standardizing processes and implementing project tracking, resource allocation, and reporting systems, so that leaders see utilization, bookings,
delivery health, and completion cycles in real time.

Consulting Insights is here to support our MedTech partners. Whether you’re a start-up navigating the regulatory landscape towards your first 510(k) premarket notification, a mid-sized manufacturer refreshing Biological Evaluation Reports and Toxicological Risk Assessments to align with ISO 10993 or a global MedTech group charting a De Novo pathway for your next-generation device, we meet you where you are. We also support combination products that need coordinated drug and device evidence, packaging and sterilization validations ahead of launch, and remediation programs that benefit from disciplined program management leadership. When you want science, strategy, and execution operating as one to streamline the path to FDA authorization, Eurofins is your trusted partner.