Our aim is to deliver clinically relevant evidence.
From concept to market adoption, we offer Medical and AI expertise to generate clinically relevant evidence for regulated Software as a Medical Device (SaMD) products.
Pre-submission (Q-Sub)
Pilot and pivotal study design
Scientific publication roadmap
Clinical implementation strategy
Human factors (usability) assessment
Standalone performance assessment
Image processing/quantification
Clinical reader study (CADe, CADx)
Ground truth and reads by US board certified sub-specialty physicians
Shadow-mode ‘real-world’ performance analysis
Clinical workflow impact assessment
Patient outcome and economic benefit
Monitoring & post-market surveillance with potential for product enhancement
Usability and human factors testing