Spinal medical devices and combination products have been a focus for MCRA’s integrated service offerings since inception.
Our Experience in Spinal Technology
Guided by decades of experience and industry know-how, in combination with firsthand global regulatory experience, MCRA Spine is the leader in assisting clients in the entire spinal medical technology life cycle, from research and development, through commercialization.
MCRA's expertise with spinal devices has been strengthened through projects with over 500 spine medical device companies in the past 20 years. These projects range from regulatory strategies for design concepts all the way through FDA Pre-Submissions and the ultimate marketing submissions, including 510(k)s, De Novos, and PMAs.
MCRA’s team has extensive experience with spine devices including the following technologies:
- Cervical/Lumbar Disc Replacements
- Posterior Stabilization
- Annular Repair
- Nucleus Augmentation
- Combination Devices & Fusion Biologics
- Interbody Cages
- Pedicle Screw Systems (Occiput - Sacral Spine)
- Nonfusion Scoliosis Correction & Stabilization
- Anterior Cervical/Lumbar Plates
- Instrument Navigation Systems
- SI Joint Fixation
- Facet Fixation
- Vertebral Body Replacements
- Vertebral Augmentation (e.g., Kyphoplasty)
- Laminoplasty Plates
- Bone Void Fillers
- Spinous Process Plates
MCRA is routinely at the forefront of the MedTech industry, helping clients navigate the ever-changing guidance across the globe for all device types, manufacturing processes, and materials in the spine industry. MCRA understands and believes in the total product lifecycle to foster device generation changes and will assist clients with design strategy, including consideration of the regulatory value of design iterations and real-world evidence collection.
As a leading advisor to spinal medical device companies, we offer a wide range of capabilities designed to serve our clients. These include our global regulatory expertise, comprehensive CRO services, reimbursement and market access, quality assurance, healthcare compliance, and cybersecurity.
No matter what we do for our clients, our goal is always to provide the best services to help them achieve their goals with regard to product development and commercialization. Our portfolio of services for spinal technology manufacturers ensures we can assist our clients through every stage of their innovation process. From ideation to pre-market development to regulatory approval and widespread market use, we serve as stewards of technology. Our strong sense of social responsibility is a core component of what we do, and it fuels our drive to bring the most advanced medical technologies to those who need them the most. These are the qualities that have carried us to a position of leadership within the industry.
MCRA’s spinal technology team brings decades of combined expertise throughout all areas of our core capabilities. They give us the ability to take on projects of virtually any size and complexity.
Meet MCRA’s team of knowledgeable spinal industry experts.
Margeaux Rogers, M.S., RAC
Spine Device Services
Spine Clinical Research Organization (CRO)
Our proven, world-class facilities and talented staff members help us support our clients’ journey to bring devices to market.
- Spine US Regulatory
Spine Global Regulatory
We have the in-house experts who bring experience and know-how needed to guide spine devices through the complicated global approval processes.
- Spine Reimbursement, Health Economics, and Market Access
Spine Quality Assurance
We ensure all the proper procedures for document control, R&D, risk management, and more are being followed so our clients don’t have to worry.
Spine Healthcare Compliance
Our expertise makes it much easier for clients to navigate the complexity of today’s legal and regulatory environment.
- Spine Cybersecurity