Non-GLP Preclinical Proof of Concept Studies for Medical Devices
Experience Matters. Why Companies Choose NAMSA.
Fully Equipped ORs and Cath Labs in US and Europe
Labs in US and Europe Offering Preclinical Services
Non-GLP Preclinical Projects in Last 12 Months
Surgeons and Interventionalists on Staff
Deep Expertise in Preclinical Research for Medical Devices Under Development
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 next steps in their research, development, and testing processes.
Non-GLP proof of concept studies receive less regulatory scrutiny and do not have the same archive and report standard requirements as GLP studies, making them a cost-effective option. As a result, non-GLP studies can also be scheduled and carried out more quickly due to shorter testing durations, smaller sample sizes, and faster report delivery.
Finally, a non-GLP study can be very useful in providing important insights and data on how a device is performing in vivo—an important step before Sponsors invest in a GLP study. Pricing can be optimized if both non-GLP and GLP studies are completed at NAMSA.
Do We Have Expertise With Your Device?
Want to learn more about our preclinical experience for your specific category of device?
Numerous Models for Early Feasibility and Proof Of Concept Studies
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.
Although NAMSA’s surgical staff is equipped with all the necessary tools to support your entire procedure, we also provide individual services to support your preclinical needs. Interested in having your key opinion leader (KOL) or design team personnel work with your product? No problem. The NAMSA team will fill in the necessary gaps in procedure roles so that your staff can concentrate on their duties during the implant or treatment procedure.
NAMSA Lab Equipment and Facilities
View a list of equipment on this page.
Meet Our Preclinical Experts
Explore the depth of our team’s expertise.
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Jack Risdahl, DVM, PhD
Principal Strategy Consultant, PreclinicalView Bio -
Gaëlle Clermont, PharmD, PhD
Principal Strategy ConsultantView Bio -
Michael A. Jorgenson, BS
Principal InterventionalistView Bio -
Tyler LaMont
Senior InterventionalistView Bio -
Katie Miedtke
InterventionalistView Bio -
Corey Leet
Director, Regional Preclinical and In-Vivo Biocompatibility OperationsView Bio
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