We are leaders in designing and remediating quality management systems under strict and changing standards for neurosurgical device companies. MCRA ensures compliance with ISO 13485, FDA Quality System Regulation, and other global QMS requirements, with special emphasis in establishing procedures for regulatory compliance tailored to your product line and target markets.
Contact a Neurology Quality Assurance Expert
Neurology & Neurosurgery Experience
MCRA offers unparalleled support to develop quality systems compliant with ISO 13485, FDA Quality System Regulation and other global QMS requirements to support development of neurological and neurosurgery devices. Our interdisciplinary team will help you assure ongoing compliance with design control procedures for your devices all the way from device conception through release to market.
Some key neurology and neurosurgery therapy areas of expertise include:
• 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
Quality Assurance Services
Our team offers setup of procedures for document control, R&D, risk management, software development, supplier evaluation, and control of measurement equipment, amongst others.
Our comprehensive quality assurance and manufacturing services include:
• Quality System Development
• Gap assessments
• Manufacturing and materials
• Mobile apps and software
• Mock inspections
• Perform internal quality system audits
• QA support
• Technical documentation and technical submissions