LSR offers deep technical expertise and operational support for medical product development and clinical validation. We're experts in the use of medical imaging for medical device development and evaluation, including SaMD.
LSR produces specialty radiology data for product R&D. For machine learning (ML) applications, we procure and label medical images to train new ML algorithms. For device design applications, we analyze medical images to develop custom reference data for novel implant designs.
In collaboration with independent test facilities and human factors experts, we evaluate novel device designs and software algorithms. Our product-specific test protocols and technical reports support iterative product development, standalone validation, and clinical study planning.
We review and verify quality systems for compliance to applicable regulatory requirements. Depending on the stage of product development, we guide phased updates to quality systems in preparation for future clinical trials and post-market deployment in the US and Europe.
We partner with regulatory strategists and CROs to support clinical study design, planning, and execution. We offer expert guidance on protocol design, imaging endpoint selection, and independent review. We also refer experts for medical monitoring, event adjudication, and DSMBs.
Using data from clinical trials and research studies, we perform 'deep-dive' analyses of product performance and outcomes. We investigate factors affecting clinical outcomes and identify disease characteristics and patient variables predictive of product success.
We author technical reports and expert narratives on product performance and differentiation. We synthesize the relevant literature and outcomes to deliver insight on factors affecting product efficacy and utility. Our work guides post-market planning and publication strategies.