Non-GLP Preclinical Proof of Concept Studies for Medical Devices
Your Choice for Non-GLP Preclinical Medical Device Testing
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 Testing for Medical Devices Under Development
Non-GLP studies conducted early in the development process can minimize the risk of failure during GLP preclinical studies and help Sponsors determine ideal next steps.
These proof-of-concept studies receive less regulatory scrutiny and don’t have the same archive or reporting requirements as GLP studies, making them a more cost-effective option. A non-GLP study also provides valuable in vivo data on device performance—an important step before investing in a GLP study.
With NAMSA, your non-GLP testing can be scheduled and completed quickly thanks to shorter testing durations, smaller sample sizes, and faster report delivery. Pricing can also be optimized when both non-GLP and GLP studies are completed through NAMSA.
Do We Have Expertise With Your Device?
Want to learn more about our preclinical experience for your specific category of device?
Early Feasibility and Proof-of-Concept Studies
Building on insights from non-GLP testing, NAMSA’s early feasibility and proof-of-concept studies help teams evaluate device safety and performance before regulatory submission. Conducted in advanced preclinical environments, these studies inform design refinement and guide the next phase of development.
- Early Feasibility Studies: These studies assess device safety and function in limited clinical use. NAMSA’s multidisciplinary teams support protocol development and data analysis to accelerate transition to pivotal preclinical trials.
- Proof-of-Concept Studies: Conducted in vivo within NAMSA’s state-of-the-art labs, these studies provide early validation of device design and performance. They allow rapid iteration, cost-efficient testing, and actionable data that can help strengthen subsequent GLP programs.
NAMSA remains a trusted partner in preclinical and early-stage development thanks to our decades of experience supporting the MedTech community. Our surgical teams can lead full procedures or collaborate with your KOLs and design personnel to ensure successful, stress-free studies.
Ask about our special preclinical program for MedTech startups
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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