Areas of Expertise

Urogenital

Organ preservation systems must keep kidneys viable during transport where every minute of ischemia damages tissue. Stone fragmentation devices need to break calculi effectively without injuring ureter walls. We validate both with GLP protocols FDA reviewers recognize.

Urological device testing facility with cystoscopy and fluoroscopic imaging equipment

Our Urologic Capabilities

Renal preservation platforms and lithotripsy systems each demand their own validation approach. Our surgical suites and advanced imaging capabilities replicate the conditions your device will face clinically.

Our surgical models and regulatory track record provide the safety and performance data FDA reviewers expect. We understand renal function assessment, urological procedures, and what makes urogenital testing different.

Complete Urogenital Capabilities

Renal Transplantation

Here is the kidney preservation challenge. Organs must remain viable during transport where every minute of ischemia matters. Your preservation system needs to maintain perfusion, oxygenation, and metabolic function throughout clinical transport durations. We monitor perfusion parameters, metabolic markers, and tissue oxygenation continuously. We measure cellular injury markers and glomerular filtration capacity following reperfusion. Our GLP protocols support regulatory pathways following ISO 13485 requirements and FDA transplantation device guidance for hypothermic machine perfusion, normothermic preservation platforms, and static cold storage systems.

Stone Retrieval

Stone fragmentation is about precision. Your device must break calculi effectively while minimizing tissue trauma. Different stone compositions require different energy approaches. We test lithotripsy performance through standardized stone models that replicate varying composition and hardness. We measure fragmentation efficiency, particle size distribution, and energy delivery accuracy. Our testing addresses extracorporeal shock wave, laser, and ultrasonic fragmentation devices following IEC 61846 standards with GLP studies supporting comprehensive safety and effectiveness validation.

Ready to Start Your Urogenital Program?

Let's discuss your device and what regulatory pathway makes sense. We'll design a validation strategy that addresses your specific urological device challenges.

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