Brain and spinal cord devices face zero tolerance failure modes. Your shunt must drain cerebrospinal fluid reliably without clogging or over draining. Your dural sealant needs to prevent CSF leaks while remaining completely non-toxic to neural tissue.
Your dural sealant has to prevent CSF leaks without causing neurotoxicity. Your neuromodulation device needs precise electrode placement. The central nervous system is unforgiving.
We test these devices in conditions that replicate what happens in neural tissue. Our 40 years of neurosurgical testing experience and validated CNS models provide the safety data regulatory reviewers expect. We understand what makes neurologic testing different.
Here's what makes shunt testing challenging. CSF must drain when pressure is too high but not so fast that it causes complications. Your valve needs to respond to real intracranial pressure changes. We test shunt performance using validated hydrocephalus models that replicate elevated pressure and altered CSF dynamics. We measure valve accuracy, flow rates, and catheter patency. This addresses both 510(k) and PMA pathway requirements for fixed pressure valves and programmable systems.
Dural sealants face a tough test. Intracranial pressure pushes against your seal throughout healing, and neural tissue cannot tolerate toxic materials. We measure adhesion strength using standardized burst pressure protocols and track tissue response at the dural interface. Our GLP protocols support submissions across fibrin-based, PEG, and biological platforms following ISO 10993 standards including neurotoxicity assessment per FDA neurological device guidance.
Spinal cord stimulation is about location. Your electrode array needs precise epidural space placement to modulate pain signals and remain safe during chronic implantation. We test lead placement using fluoroscopic guidance to document navigation and positioning relative to target spinal segments. We measure stimulation thresholds, current distribution, and neural recruitment. Our protocols evaluate tonic and burst waveform patterns for both paddle arrays and percutaneous leads following IEC 60601 standards for Class III PMA requirements.
Let's discuss your device. What it needs to prove. What regulatory pathway makes sense. We'll design a validation strategy that addresses your CNS device challenges.
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