Contact a Neurology Regulatory Expert

Neurology & Neurosurgery Experience

MCRA’s team of experts has successfully navigated hundreds of US FDA submissions ranging from 510(k)s to PMAs involving advanced first-in-class neurosurgical devices. 

MCRA is a world-class provider of regulatory strategy and advice for neurological and neurosurgery devices, including: 

•    Ablation devices

•    Ambulation

•    Cognitive function devices

•    Cranioplasty devices

•    Electrophysiology

•    Histopathology of device in situ

•    Hydrocephalic shunt devices

•    Migraine

•    Nerve cuffs

•    Neural implants

•    Neurodiagnostics devices 

•    Neuroimaging devices

•    Neurointerventional devices (including stents, embolization devices, flow diverters, thrombectomy devices, clot retrievers and others)

•    Neurostimulation

•    Neurostimulation devices (including hypoglossal, vagal, splanchnic, vertebral, baro receptor, renal, sciatic, vertebral, and spinal cord)

•    Pain relief

•    Prosthetics

US Regulatory Services

MCRA has industry leading specialization in the full spectrum of neurological and neurosurgery medical devices, with strong regulatory and scientific leadership offering deep expertise in the complex neurology space.

Our comprehensive regulatory services include: 

•    Global and US regulatory strategy

•    Regulatory landscape assessment

•    Gap analysis

•    Investigational Device Exemption (IDE)

•    De Novo

•    510(k)

•    Premarket Approval (PMA)

•    FDA appeals

•    FDA training

•    FDA warning letters and 483 observations

•    Pre-clinical testing plan

•    Clinical testing plan

•    Due diligence services

•    Agency interaction

•    Device classification

•    Import/export

•    Labeling

•    FDA meeting strategy

•    Real-time reviews

•    Device listing

•    Establishment registration

•    Regulatory file letters

•    Medical device reporting

•    IDE Reporting

Contact a Neurology Regulatory Expert