PRECLINICAL
LABS & FACILITY
Our State-of-the-Art Preclinical Testing Facilities
Walk into our facility and you'll immediately notice something different. Our three dedicated operating rooms provide unmatched versatility for diverse study protocols. Two cath labs handle interventional procedures while our surgical suite manages complex operations. We can dedicate the optimal environment to your study without scheduling conflicts.
Each room comes equipped with complete GLP compliance. They meet every FDA standard, with monitoring systems for cardiovascular, orthopedic, and neurosurgical procedures.
Our room layouts and data collection systems were specifically designed for large models, device implantation, surgical training, and physician education. That helps insure no delays or downtime so you stay on schedule.
The Tools Behind the Science
Imaging Technology That Sees Everything
Your cardiovascular devices need more than basic assessment. They need the kind of evaluation that major cardiac centers provide. Our structural heart imaging services have invested in technology that captures live hemodynamic data during TAVR, SAVR, and coronary procedures. Flow studies that prove your device works as intended. 3D reconstruction showing exactly how your device fits anatomically. Extended follow ups that tracks performance over months, not just weeks.
GE OPTIMA 220 DUAL IMAGING SYSTEM
- High-resolution X-ray for orthopedic studies
- Fluoroscopic guidance during procedures
- Multiple positioning options for complete evaluation
- Digital enhancement for better visualization
SIEMENS SOMATOM FLASH ECHO CT SCANNER
- Resolution fine enough to catch submillimeter details
- Contrast studies showing blood flow and tissue response
- 3D data that makes regulatory reviewers happy
- Long-term imaging showing integration and healing
PHILIPS ULTRASOUND SYSTEM
- Sharp cardiac visualization for structural heart studies
- Precise vascular access during complex procedures
- Continuous monitoring while devices deploy
- Follow-up imaging at scheduled intervals
Specialized Imaging That Goes Deeper
STRYKER LAPAROSCOPIC TOWER
When you need absolute precision, 4K visualization changes everything:
- Ultra-clear imaging for exact device placement
- Built-in recording for training and validation
- Documentation from multiple angles for submissions
- Remote streaming for off-site monitoring
GE VIVID E9
Specialized vascular work requires specialized tools:
- Doppler studies proving device performance
- Vessel analysis supporting biocompatibility studies
- Extended protocols showing long-term safety
- Quantitative data meeting regulatory requirements
Expertise Matched to Your Device Type
- Cardiovascular Applications: Complete evaluation from initial deployment through extended follow-up
- Orthopedic Solutions: Imaging protocols supporting integration studies, stability assessment, and biocompatibility evaluation
- Neurological Devices: Monitoring designed specifically for CNS safety and performance evaluation
- Regenerative Medicine: Healing protocols for wound care and dermatology applications
- Combination Products: Analysis capabilities for complex drug-device combinations
Standards You Can Count On
AAALAC International accreditation represents our commitment to ethical animal care. GLP compliance under 21 CFR Part 58 ensures every study meets regulatory expectations. Our quality assurance programs protect data integrity throughout your development process.
This information serves educational purposes and doesn't constitute medical, regulatory, or legal advice. Requirements vary by device classification, intended use, and jurisdiction. Consult qualified regulatory professionals for device-specific guidance.