MCRA’s leading 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 Spine Regulatory Expert
Spine 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 spine devices, including:
• 3D printed devices
• Annulus repair
• Atlanto-cervico-thoracic fixation systems
• Bone void fillers
• Cervical interbody cages
• Combination devices
• Disc nucleus replacement
• Dura/vertebrae anti-adhesion
• Hydrocephalic shunt devices
• Instrument navigation systems
• Laminoplasty plates
• Lumbar interbody cages
• Pain relief
• Pedicle screw systems
• Reconstruction of intervertebral disc
• SI-joint screws
• Spinal fusion
• Spine surgery
• Total disc replacement
• Vertebral augmentation
• Vertebral body replacements
International Regulatory Services
MCRA has industry leading specialization in the full spectrum of musculoskeletal medical devices, supporting hundreds of clients seeking regulatory designations, clearances, and international registrations with proven track record of hundreds of Technical Files, Dossiers and CERs in oUS markets.
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)