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Medical Device Preclinical Research
Deep Preclinical Expertise
When it comes to the successful preclinical testing of medical devices, experience matters. NAMSA has the largest depth of therapeutic expertise of any development partner on the planet. That equates to unparalleled preclinical laboratory support for sponsors from all over the world, at our GLP-compliant and AAALAC-accredited facilities in the United States and Europe.
Our global teams are experts at designing and executing studies to bridge preclinical safety endpoints to proposed clinical endpoints, allowing clinical labs to standardize measurements and obtain expert interpretations of results. We can also support early feasibility testing with non-GLP studies, intended to provide iteration and proof-of-concept prior to investment in GLP programs.
Medical Device Preclinical Services
NAMSA’s preclinical research services allow you to evaluate your product or device for safety and performance. Our GLP-compliant studies follow strict regulatory guidelines and utilize both small and large preclinical models to assess multiple treatment modalities and implantation requirements, including:
- Cardiovascular/cardiothoracic
- Dental studies
- Dermal studies
- Electrophysiology studies
- Gastrointestinal studies
- Hemostasis studies
- Neurovascular
- Ophthalmology studies
- Orthopedics studies
- Pulmonary studies
- Thrombosis/thromboresistance studies
- Urogenital studies
- Vascular studies
- Wound healing studies
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.
NAMSA Lab Equipment and Facilities
NAMSA’s surgical staff — including veterinarians, ASR-certified surgeons and interventionalists, and Board-certified pathologists— are equipped with the necessary tools to support your entire procedure or to fill procedural role gaps as needed. When you need thorough laboratory research or preclinical testing of medical devices, NAMSA’s team has the technology and experience needed to successfully execute your study.
NAMSA lab facilities contain observation rooms with two-way audio communications and high-definition video recording systems. We also offer the ability to livestream procedures for remote monitoring which includes two-way audio communications as well. Each facility also includes a sponsor suite for viewing procedures.
Computed Tomography (CT)
- Dual-Source, 128-slice clinical CT
- Micro-CT
- 3D Optical Coherence Tomography (OCT)
Fluoroscopy
- Fixed Cath Lab C-Arms
- Mobile C-Arms
Ultrasound
- Transthoracic Ultrasound (TTE)
- 3D Intracardiac Ultrasound (ICE)
- 3D Transesophageal Ultrasound (TEE)
- Intravascular Ultrasound (IVUS)
Endoscopy Towers
X-Ray Imaging, including Faxitron
Orthopedic Console
Biomechanical Testing (Instron)
Phacoemulsificator
MRI Access
Sponsors Trust NAMSA to Do It Right the First Time
Medical Device Preclinical Projects Last Year
Fully Equipped ORs and Cath Labs in US and Europe
Labs in US and Europe Offering Preclinical Services
Focused on Medical Device Research Since 1967
WHY CLIENTS CHOOSE NAMSA
Meet NAMSA’s 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 -
David Reimer, MD
SurgeonView Bio