Clinical evaluation for SaMD and AI devices
Clinical evaluation for SaMD and AI devices
We specialise in clinical evaluation for software medical devices, including health apps, SaMD, AI, and other medical devices.
We specialise in clinical evaluation for software medical devices, including health apps, SaMD, AI, and other medical devices.
Our team guides you through every stage, from defining the Intended Use to creating a clinical evaluation plan, performing systematic literature reviews, designing and analyzing clinical investigations, and preparing detailed reports.
Our team guides you through every stage, from defining the Intended Use to creating a clinical evaluation plan, performing systematic literature reviews, designing and analyzing clinical investigations, and preparing detailed reports.
Our team helps convert complex data into clear evidence
Our team helps convert complex data into clear evidence
Defining Intended Use early to align development with clinical goals and regulatory expectations
Planning and structuring the clinical evaluation with clear methodology and timelines
Conducting systematic literature reviews to build evidence from published data
Designing and managing clinical investigations to generate robust, device-specific outcomes
Analysing results, preparing reports, and translating findings into clear, defensible evidence
Writing and maintaining Clinical Evaluation Reports (CER) while ensuring continuous compliance through Post-Market Clinical Follow-Up (PMCF)
Providing transparent, data-driven insights that support approval, adoption, and long-term trust