MCRA’s neurosurgical experts are specialized in achieving success with international regulatory bodies. Our team has industry leading experience with global regulatory strategy and deep understanding of the device lifecycle assisting through the developmental process, including conception and design considerations, pre-clinical and clinical testing, regulatory application through clearance/approval, and commercialization, providing MCRA's clients with the best representation to regulatory agencies in demonstrating the science, safety, and efficacy of their technologies.
Contact a Neurology Regulatory Expert
Neurology & Neurosurgery Experience
MCRA’s team of experts has successfully navigated hundreds of international regulatory submissions. Our expertise extends to European, Australian, and Canadian markets, successfully remediating Technical Files and Clinical Evaluation Reports (EU CER) for compliance with MEDDEV 2.7.1. Rev. 4 for hundreds of medical devices across the industry.
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
International 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:
• Agency/Notified Body interaction
• Clinical testing plan
• Design dossier and technical file gap assessment
• Device classification
• Device listing
• Due diligence services
• Establishment registration
• European Technical Files and Clinical Evaluation Reports (EU CER) compliant to the EU MDR
• Gap Assessment of Key Chemical/Material Restrictions (such as those found in REACH, RoHS, BPR & CLP)
• Global regulatory strategy
• Import/export
• Labeling
• Medical device reporting
• Mock audits
• Notified body submission/Response
• Post-market surveillance
• Pre-clinical testing plan
• Quality system gap assessment
• Regulatory file letters
• Regulatory landscape assessment
• Training (EU MDR)