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
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.