Medical Device Preclinical Research

Non-GLP Preclinical Studies

Non-GLP studies at an early stage in the development process can minimize the risk of failure during GLP preclinical studies and help Sponsors decide the next steps in their research, development, and testing processes.

Working in state-of-the-art laboratories, our highly-trained experts utilize a broad range of trusted in vivo models and analysis tools to deliver accelerated, cost-efficient results.

Combining decades of experience in therapy delivery systems and implantable medical device research, NAMSA serves as the industry’s premier destination for preclinical interventional research.

GLP Preclinical Research Studies

The NAMSA team has extensive experience conducting GLP-compliant studies on a vast array of medical devices. NAMSA offers cutting-edge equipment and techniques. We have numerous digital catheterization labs featuring state-of-the-art Fixed C-arm platforms. We can accommodate your timelines no matter how large the study design or last minute the request. Each cath lab features dedicated workstations for real-time quantitative analysis and evaluation.

Preclinical Pathology Services

NAMSA pathology labs are designed for high volume to meet and exceed all of your tissue and device collection requirements. We operate fully-equipped histopathology and SEM/TEM laboratories in our facilities to help meet a wide variety of preclinical testing needs.

The NAMSA pathology labs are operated by qualified histotechnicians and have Board-Certified pathologists who oversee gross necropsies, interpret histopathology slides, and write reports evaluating the safety of products. The labs also have advanced equipment for the precise sectioning of all medical devices, using paraffin, plastic thin microtomy, laser microtome systems, and plastic EXAKT ground sectioning.

Bioskills and Human Factors

Expectations from regulators for physician training and human factors testing are continuing to grow. It’s more important than ever to bring physicians, engineers, and technical staff into the simulation lab to learn and train on medical devices. It is essential that they overcome the learning curve with these complex systems as they accurately simulate the feel and rigors of an operating room (OR) or catheterization lab. NAMSA’s facilities can fulfill this need, as well as host or train your internal trainers with expertise from our staff.