Neurological technologies are at the core of MCRA's 150+ years of combined experience.
Bringing Neurosurgical & Neurological Products to Market
Introducing a new medical product to the market is no small feat, especially in a segment as complex as neurology. Neuro medical device companies must navigate a wide range of challenges ranging from common issues shared by all manufacturers to those unique to healthcare. For instance, they must be hypervigilant when it comes to quality control so they can prevent harm to patients and avoid costly recalls. They also need to be concerned about regulatory compliance, given the intense scrutiny under which the industry operates. Managing the clinical trials that will determine the success of their concepts also requires extensive expertise that many organizations don’t always have internally at their disposal.
Our Experience in Neurological Devices
MCRA Neuro brings unparalleled passion and expertise to all projects from companies of all sizes. Our neurosurgical device consultants provide strategic advice at the beginning stage, clinical stage, marketing stage, and post-marketing stages of device development. Our goal is to help you achieve your objectives as quickly and efficiently as possible. We bring a wealth of knowledge and know-how that ensures our clients can bring their products through the development process without delays. Our team of neurological device consultants can guide you through all the challenges you may face. With our help, your company can ensure quality, efficiency, and compliance every step of the way.
We recognize that the neurological medical devices landscape covers a wide array of technologies and intended uses, all with varying degrees of complexity. Our subject matter expertise has both the depth and breadth to match this diverse landscape. The following represents a sample of our current knowledge base:
- Neurological Surgical
- Neurological Diagnostic
- Neurological Therapeutic
MCRA's highly-specialized approach has culminated in expert-level knowledge of, but not limited to:
- 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, and spinal cord)
- Pain relief
Our clients choose us because we offer an ecosystem of resources that is unique to neurological devices, such as biocompatibility and digital health. We provide these best-in-class services to bring new neurosurgical technologies to market. Our goal is to help clients achieve their product development and commercialization goals in the most effective and efficient manner possible. Working with our team of experts, neuro medical device companies can have a smooth experience throughout every step of the innovation process. From initial ideation through pre-market development to widespread market use, we will be there to make sure new neurology devices find their way through the entire lifecycle successfully from start to finish. Our passion to bring the most advanced medical technologies to those who need them most fuels everything we do.
Meet Team
It takes a considerable amount of expertise to support the development of neuro devices, and that’s precisely what MCRA brings to the table. Our neurology consultants have the unique blend of knowledge and hands-on experience in the neurodiagnostics market to handle any project no matter how large or complex. Meet our neurological industry experts below.
Neurological Device Services
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Neurological Clinical Research Organization (CRO)
With our collection of proven expertise, world-class facilities, and dedicated professionals, we have the resources needed to support our clients on their journey to the marketplace. Our neurology CRO services work hand-in-hand with your organization to serve as an extension of your own team.
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Neurological US Regulatory
Count on us to provide the knowledge and specific experience required to shepherd neurological devices successfully through the complicated FDA regulatory process. You can depend on our expertise to make compliance as smooth and efficient for you as it can be.
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Neurological Global Regulatory
Navigating the waters of international medical device commercialization requires strong regulatory and scientific leadership, both of which we provide. With our international neurosurgery marketing experience, you can open the door to new markets and grow your business.
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Neurological Reimbursement, Health Economics and Market Access
Trust our more than 50 years of experience when it comes to reimbursement, health economics, and market access services. Neurology medical device companies depend on our knowledge base to make the financial side of their businesses as effective as possible.
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Neurological Quality Assurance
Our clients depend on us to ensure all proper procedures for document control, R&D, risk management, software development, supplier evaluation, control of measurement equipment, and more are in place and followed. We know how critical it is to have absolute confidence in your offerings, and our neurological device consultants are here to help you achieve that.
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Neurological Healthcare Compliance
Neurological clinical trials present a unique set of complexities that require meticulous oversight. Our compliance team partners with you to provide a continuous process of performance evaluation, ongoing assessments and planning to ensure compliance and alignment with evolving regulatory standards.
Learn more about our neurological compliance assistance here.
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Neurological Cybersecurity
Advanced neuroscience medical devices deserve the most robust defenses against cybercrime and data breaches to protect those who use them, and our solutions provide that. When you choose to work with us, you can rest assured we will close any gaps that may exist in your cybersecurity measures to provide total protection.