At Franklyn Health, we help manufacturers and sponsors ensure that their medical device has the right pathway, and manage the competent-authority and ethics submissions that follow, across the EU and beyond. Whether you are running your first feasibility study or planning PMCF on a marketed device, we can help you find the most efficient compliant route.
Contact our team to discuss your clinical investigation strategy.
Earlier this week, our CEO, Rob Bedford, had the pleasure of speaking at the COG CRO Summit UK. His talk focused on the importance of choosing the right CRO partner for MedTech clinical studies.
The key message was simple: medical device and IVD studies are fundamentally different from biopharma studies. Choosing a MedTech-focused CRO can make all the difference, from shaping your regulatory strategy and clinical trial design to study execution and ultimately regulatory submission.
The Q&A that followed covered topics including:
➤ The evolving role of AI in clinical research
➤ ISO standards and quality systems
➤ Building strong sponsor–CRO partnerships