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Preclinical Research Services


Innovative surgical instrumentation and certified medical experts to fully support your preclinical, interventional and surgical research needs.

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Annual Preclinical Projects


Cath Labs


Annual GLP Surgical Research Projects

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 — backed by over 50 years in business. That equates to unparalleled preclinical laboratory support for sponsors in the United States, United Kingdom, Ireland, Spain, France, Germany and many other countries worldwide.

NAMSA’s preclinical research services support all model types, treatments and implant requirements, including:

  • Cardiovascular
  • Dental
  • Dermal
  • Electrophysiology
  • Gastrointestinal
  • Neuromodulation
  • Orthopedics
  • Pulmonary
  • Urogenital
  • Wound Healing 
  • and many others

Our highly sought-after global teams are experts at helping utilize data 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 surgical studies intended to provide iteration and proof-of-concept prior to an investment in GLP programs.

NAMSA keeps cutting-edge imaging technology at the heart of all preclinical research services, including:

  • Diagnostic imaging for visualizing implants
  • Diagnosing defects or disease
  • Documenting research outcomes

In addition, NAMSA’s surgical staff — including Doctors of Veterinary Medicine and Academy of Surgical Research-certified — 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 is here to provide the expertise.



NAMSA Lab Equipment and Facilities

Bioskills Cadaver and Simulation Labs

Performing human cadaver studies since 2006, NAMSA is an approved human cadaver lab site authorized to perform device evaluations. We provide whole body cadavers as well as partial cadavers or various tissues. Combining our access to tissues with our equipment and expertise allows us to provide device evaluations at the highest levels. We also provide in vivo tissue for use in wet lab device evaluations.


The FDA’s expectations for physician training and human factors testing within the medical device arena 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 devices. It is essential that they be familiar 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.

Imaging Equipment 

  • Dual Source Computed Tomography (Siemens Somatom® Definition Flash)
  • Fluoroscopy (Siemens AXIOM Artis Zee™ Digital Cath Labs, Siemens Avantic™ and Cios mobile c-arms)
  • Intracardiac (ICE) and Duplex Ultrasound (Siemens Cypress and Sequoia™)
  • Intravascular Ultrasound (IVUS) (Boston Scientific POLARIS™)
  • Optical Coherence Tomography (OCT) (Abbot Ilumien Optis)
  • Stryker & Olympus Endoscopy Towers

Lab Space

  • Three (3) fully-equipped operating suites
  • Six (6) hospital-grade digital cath labs
  • Observation rooms
  • Two-way communications
  • Video cameras
  • Quadview HD video recording systems
  • Sponsor suite for on-site viewing of procedures
  • Webcasting and virtual viewing capabilities for off-site monitoring, including 2-way communication

Specimen Preparation Techniques

  • Fresh or Fixed Tissue
  • Full or Partial Perfusion
  • Resin and Silicone Casts
Imaging and Data Collection Modalities

NAMSA offers cutting edge equipment and techniques designed for cardiovascular and peripheral vascular research. We have five digital cardiac catheterization labs featuring the Siemens AXIOM Artis Zee fixed C-arm platforms. So we are able to accommodate your timelines no matter how large the study design or last minute the request.

We feature dedicated Siemens Leonardo workstations in each cath lab for real-time quantitative coronary/vascular angiography (QCA/QVA) analysis and evaluation.

Quantitative angiography may be augmented by additional types of intravascular imaging, including optical coherence tomography (OCT), intravascular ultrasound (IVUS), and intracardiac ultrasound (ICE).

Our preclinical testing and research services include access to a dedicated picture archiving and communication system (PACS) server that’s available for storing and retrieving cases.


  • 3D Rotational Fluoroscopy
  • Dual Source Computed Tomography (CT) (Siemens Somatom® Definition Flash 128 slice scanner)
  • Fluoroscopy (Siemens AXIOM Artis Zee™ Digital Cath Labs, Siemens Avantic™ and Cios Mobile C-arms)
  • EP Recording (Boston Scientific LabSystem™ PRO)
  • Ultrasound (ICE, TEE, TTE, Peripheral Sonography Capabilities)
  • Intravascular Ultrasound (IVUS) (Boston Scientific POLARIS™)
  • Optical Coherence Tomography (OCT) (Abbott Ilumien Optis)
  • Diagnostic Imaging Modalities through Partnerships

NAMSA also has long-standing partnerships with a network of trusted experts when additional diagnostic imaging and analysis is needed.

  • MRI (Siemens Avanto 1.5T, GE Signa HDx 3.0T)
Interventional and Surgical Research

NAMSA is proud to offer interventional and surgical research for a variety of medical devices worldwide. Working in state-of-the-art laboratories, our highly-trained experts utilize a broad range of trusted In Vivo models and analysis tools, including six (6) Siemens Cath Labs, a 128-slice CT Scanner, and more, 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 à la carte 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.

All of NAMSA’s surgical suites are maintained to hospital standards. Every suite features temperature and humidity control, with HEPA filtration for a full aseptic surgical field.

We also understand the criticality of complying with methods and regulations within the European Committee for Standardization (CEN), U.S. Food and Drug Administration (FDA) and other international guidelines to provide reliable, accurate outcomes.

NAMSA has extensive experience in the following interventional models and device product testing:

  • Cadaveric Non-Clinical Testing
  • Cardiac Surgery
  • Coronary and Peripheral
  • Dental
  • Dermal Wound Healing
  • Drug Coated Balloons
  • Electrophysiology
  • Embolization Devices
  • Endoscopy
  • Gastrointestinal and Urogenital
  • Transcatheter and Surgical Heart Valves
  • Neuromodulation
  • Orthopedic and Bone Healing
  • Physician Training
  • Pulmonary Therapies
  • Specialty Pathology Services
  • Stents/Graft
  • Tissue Engineering
  • Thrombogenicity Testing
Non-GLP Preclinical Surgical Research

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

Non-GLP 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.

Pharmacology and Toxicology

NAMSA offers an array of services for drug discovery programs including efficacy studies, pharmacokinetic (PK) assessments, as well as discovery and GLP toxicology services. We are pleased to offer these services in both rodent and various models, while combining our bioanalytical and histopathology capabilities to centralize your research in our state-of-the-art facilities.

With a focus on pain pharmacology, NAMSA brings years of expertise in behavioral pharmacology to bear on to your projects, helping you prioritize leads and select development candidates. Our turnaround times are unmatched and our rigorous approach to positive controls ensures that you will finish with quality data on which to base your crucial decisions.

We also understand that the development of novel therapeutics requires the development and validation of novel models and assessment methodologies. When you have chosen your development candidates, let us continue to help with your program needs through our Toxicology Services. From dose-ranging on through acute and chronic studies, and from mice to canines, NAMSA can assist you establish safety and tolerability profiles of your lead molecules.


Pathology is the gold standard for the evaluation of medical device performance and safety. The NAMSA pathology lab is designed for high volume to meet and exceed all of your tissue and device collection requirements. We operate a fully equipped, 5,000 square foot histopathology and SEM laboratory in our main facility to help meet a wide variety of preclinical testing needs.

The NAMSA pathology lab is operated by Board Certified Histotechnicians and has Board Certified Veterinary, MD and PhD pathologists who oversee gross necropsies, interpret histopathology slides and write reports evaluating the safety of products. The lab also has advanced equipment for the precise sectioning of all medical devices, using paraffin, plastic thin microtomy, plastic EXAKT ground sectioning, and SEM techniques.


Post-Mortem Exams

  • Large / Small in vivo models
  • Evans blue staining
  • Ex-vivo perfusion fixation
  • Fluorogram guided tissue harvesting
  • In-situ perfusion fixation
  • Microdissection
  • Pharmacokinetic sampling
  • TTC in-situ and ex-vivo staining


  • High Resolution radiography (Faxitron)
  • Histomorphometry
  • Scanning Electron Microscope
  • Stereomicroscopy
Specific Product Expertise


  • Abdominal Aortic Aneurysm (AAA)
  • Aortic Annuloplasty Balloons
  • Atherectomy
  • Cell and Gene Therapy
  • Chronic Total Occlusion / Total Partial Occlusion Crossing Wires (CTO)
  • Coronary Bare Metal Stents (BMS)
  • Coronary Drug Eluting Stents and Scaffolds (DES)
  • Drug Coated Balloons (DCB / DEB)
  • Embolic Beads
  • Embolic Protection
  • Endovascular Grafts
  • Guide Catheters
  • Guide Wires
  • Introducer Sheaths
  • Left Atrial Appendage Occlusion
  • Myocardial Infarction Models
  • Patent Ductus Arteriosus Closure
  • Peripheral Bare Metal Stents (BMS)
  • Peripheral Drug Eluting Stents and Scaffolds (DES)
  • Perivalvular Leak Occlusion
  • POBA Balloons
  • Renal Denervation
  • Septal Defect Closure (ASD, PFO, PMVSD)
  • Telemetry
  • Thrombectomy
  • Transcatheter Valve Replacement (TAVI, TAVR)
  • Transseptal Catheters
  • Vascular Closure
  • Vascular Stimulation


  • Cardiac Ablation
  • Cardiac Leads
  • Cardiac Rhythm Management
  • EP Recording and Mapping
  • Pulmonary Vein Ablation


  • Biliary Catheter
  • Obesity Devices


  • Carotid Sinus Stimulation
  • Epidural leads


  • Bare Metal Stents and Scaffolds
  • Drug Eluting Stents and Scaffolds (DES)
  • Lung Biopsy
  • Lung Denervation
  • Lung Volume Reduction
  • Tracheal Stent


  • Kidney Cellular Regeneration
  • Prostate Ablation
  • Uterine Ablation
Usability Testing

Human Factors Usability Testing is not just a regulatory requirement. Incorporating the User Experience in each phase of your product development is essential for safety. Unlock the potential of your product with our comprehensive usability testing services. Our expert team specializes in guiding key design and product development decisions, ensuring a seamless user experience and paving the way for commercial success. From MedTech to IVD therapeutic areas, we offer expertise in designing, implementing, and analyzing usability tests that meet global standards. Our extensive experience spans diverse evaluations across various product categories, positioning your innovation for regulatory approval and market dominance.