MCRA Dental has decades of combined experience and direct oversight from multiple former FDA personnel from the dental field.
Bringing Dental Devices to Market
Introducing a new medical technology to the market can be a complicated process. In addition to the basic concerns regarding quality control and supply chain that all manufacturers must face, dental technologies are subject to other concerns that can have a significant impact on their success. For example, there’s the complex regulatory landscape in the domestic market as well as those in the myriad territories overseas. Many dental medical device companies also may have difficulties securing reimbursement from insurance providers. In most cases, overcoming these obstacles comes down to having the proper expertise and know-how on their side. MCRA’s dental medical device consulting capabilities offer these to our clients so they can navigate their challenges and find success.
Our Experience in Dental Devices
Our mission is to provide best-in-class regulatory, clinical, and reimbursement services to help our clients achieve their product development and commercialization goals. We have structured our approach to navigating the regulatory and commercial landscape to align with the FDA's focus on the Total Product Life Cycle, a regulatory framework that integrates all aspects of product development. The battery of dental specialty services in our portfolio therefore enables us to partner with our clients through the various stages of the innovation process, from conception, through pre-market development and FDA approval, to widespread market use and payor reimbursement. As stewards of technologies intended to maintain dental health and treat dental problems, MCRA’s social responsibility is woven into the fabric of what we do and fuels our passion to bring the most advanced dental therapies to those in need.
With the help of our dental medical device consulting, our clients have the resources they need to manage every aspect of their intraoral devices’ development cycle. MCRA Dental has decades of combined experience and direct oversight from multiple former FDA personnel from the dental field, and are capable of taking on projects of any complexity, including (but not limited to) those within the following product areas:
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Additive Manufactured teeth devices (e.g., customized Implants, Crowns, Plates, Dentures, Restorations etc.)
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Bone Grafts
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Bone Substitutes
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Dental Abutments
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Dental Amalgams
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Dental Cements
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Dental Combination Products
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Dental Imaging Equipment
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Dental Implants
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Dental Membranes
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Dental Plates
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Intraosseous Fixations
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Lasers
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Mandibular Condyle Prostheses
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Maxillofacial Reconstruction Implants
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Orthodontic Appliances
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OTC Denture Cushions
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Total Temporomandibular Joint Prostheses
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Transmandibular Implants
Our Team
The experience and expertise our team brings to the table are what enable us to deliver the most successful specialty dental services. Meet our experts within this field below.
Dental Medical Devices Services
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Dental Medical Devices Clinical Research Organization (CRO)
Our support helps clients bring their products to market thanks to our world-class facilities, proven expertise, and dedicated professionals. Our dental consultation experts work hand-in-hand with our clients, serving as an extension of their own in-house teams and ensuring they have the support they need on their journey to the marketplace.
Learn more about our dental medical devices CRO services here.
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Dental Medical Devices US Regulatory
Our experts guide dental medical devices through the complex FDA process with specialized knowledge and know-how. We bring a considerable amount of expertise to ensure the process goes as smoothly as possible.
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Dental Medical Devices Global Regulatory
With our strong regulatory and scientific leadership, we help devices successfully reach various international markets. When it comes to treating teeth, devices must be compliant for maximum peace of mind, and we have the necessary expertise to ensure they meet all the relevant standards around the world.
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Dental Medical Devices Reimbursement, Health Economics, and Market Access
We are a full-service resource with more than 50 years of experience when it comes to reimbursement, health economics, and public policy services. Clients count on our experience to make certain they will maximize the revenue streams from their dental and orthopedic medical devices.
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Dental Medical Devices Quality Assurance
Trust us to handle all aspects of document control, R&D, risk management, software development, supplier evaluation, measurement equipment control, and other critical processes. Confidence is important when intraoral devices to the marketplace, and we give manufacturers faith that their products will perform as they are expected to.
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Dental Medical Devices Healthcare Compliance
We have the expertise needed to navigate the confusing legal and regulatory environments manufacturers experience. Our team works closely with clients to provide performance evaluations, ongoing assessments and planning to keep them aligned with the ever-evolving regulatory standards.
Learn more about our dental medical devices compliance assistance here.
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Dental Medical Devices Cybersecurity
Advanced medical devices require robust protection against cybercrime and hacking attempts. We specialize in identifying and resolving any gaps that might exist in the cybersecurity protecting our clients’ devices.