Beaufort has specialized expertise in medical device clinical trials, where patient safety, data integrity, and regulatory success drive every strategic decision we make.
Our in-depth experience spans the complete medical device spectrum, from traditional to breakthrough technologies, with particular depth in complex combination products, software-enabled devices, and novel materials across diverse therapeutic areas.
Our technical expertise encompasses the full range of medical device types and risk classifications. We understand the unique clinical and regulatory considerations for each category, ensuring appropriately designed studies that address specific safety and performance requirements.
Our extensive clinical experience spans all major therapeutic areas, with particular strength in cardiovascular, orthopedic, and neurological applications. We understand the unique patient populations, endpoints, and clinical environments essential for successful medical device validation in each specialty.
From hospital operating rooms to home care environments, we tailor clinical trial programs consistent with your medical device’s intended use setting. Our experience across diverse clinical environments ensures an appropriate usability assessment, risk management, and regulatory approach tailored to your specific context of use.
We guide clients confidently through complex regulatory frameworks, including US FDA 510(k), De Novo, PMA pathways, EU MDR compliance, and international market access strategies. Our approach aligns clinical evidence generation with specific regulatory requirements to optimize approval timelines.
We would not be here without all of your (Beaufort’s) diligence and hours dedicated to screening, enrolling, and managing the trial. THANK YOU!
Stay informed with expert perspectives on device development, regulatory changes, and clinical trial optimization from our experienced medical device specialists and industry thought leaders.
Get answers to some of the most common questions about medical device clinical trials and CRO services.
“Safety and performance” are the main endpoints for many medical device trials, especially in regulatory contexts (e.g., with the FDA or EMA). They often have shorter durations, smaller sample sizes, and unique considerations for surgeon/user training, device iterations, and objective rather than subjective endpoints.
MDR increased clinical evidence requirements, particularly for higher-risk and legacy devices. It requires robust clinical evaluation reports, more rigorous post-market surveillance, and often demands clinical investigation data where literature and equivalence were previously sufficient.
Sample size is based on primary endpoints, statistical power requirements, and regulatory guidance for your specific device type. Early statistical consultation is essential to avoid underpowered studies while maintaining cost-effectiveness.
Specialized device CROs like Beaufort offer technical expertise in device-specific protocols, understanding of unique regulatory pathways, experience with surgeon/investigator relationships, and familiarity with specialized endpoints that general CROs often lack.
Timeline optimization includes streamlined site contracting, centralized IRB approaches, targeted investigator selection, enhanced training, and integrated monitoring strategies. Early regulatory engagement and protocol optimization are also critical acceleration factors.
Combination products require integrated development strategies addressing both device and drug components. Coordination between CDRH and CDER/CBER pathways and a clear primary mode of action determination are essential for success.
Post-market requirements vary by device classification and regulatory pathway but may include post-approval studies, extended follow-up of pre-market cohorts, post-market surveillance, and real-world evidence collection through registries or claims database analyses.
Software as a Medical Device (SaMD) faces unique regulatory considerations, including software validation, cybersecurity requirements, interoperability testing, and adaptive algorithms. Development often follows agile methodologies, requiring specialized validation approaches.
Global device trials must navigate varying regulatory requirements, ethics committee expectations, and standard-of-care differences. Harmonized protocols with region-specific adaptations, strategic site distribution, and localized support infrastructure are critical success factors.
