Biomedical Engineering & Sciences

ESi’s consultants combine extensive education and training with a deep understanding of anatomy and physiology. Our expertise covers therapeutic and diagnostic devices—implantable, non-implantable, electromechanical, combination, drug-delivery, and software-enabled—throughout the Total Product Life Cycle. 

We assess how device factors, patient factors, and use or technique factors influence patient outcomes with medical devices, examining how these factors impact biological systems and patient health. Our analysis includes adverse events, device performance, and human-system interactions. 

Our multidisciplinary team includes engineers and scientists with advanced expertise in biomechanics, biomaterials, electrical and systems engineering, and regulatory sciences, supported by a comprehensive understanding of anatomy and physiology. Our team has experience with both FDA submissions and international regulations and addresses complex challenges by guiding clients through the intricacies of compliance, from verification and validation to risk management and post-market surveillance.  

Our nationwide laboratory network supports preclinical testing, numerical simulations, and failure analyses. We specialize in creating custom testing solutions to ensure products meet the highest standards while keeping a competitive edge.  

Our experts assist with product liability disputes, intellectual property cases, insurance claims, and due dilligence assessments for technology acquisitions. We reduce potential liabilities by creating strong risk management strategies focused on safety and compliance.