Comprehensive Dental Device Clinical Trial Solutions
Orthodontic and dental devices are instruments designed for the treatment or restoration of dental structures. Eclevar facilitates effective clinical studies for dental device firms, regardless of their scale by simplifying the clinical trial procedure.
Our team possesses extensive industry experience in global regulatory strategies and an in-depth understanding of the device lifecycle. We guide clients through every stage of development, from conceptualization and design considerations to pre-clinical and clinical testing, regulatory applications, clearance/approval, and commercialization. Contact us to learn more.
Quality Assurance for Dental Devices
We offer quality management systems within standards for ISO 13485, MDR, FDA Quality System Regulation, and other global QMS demands. Our emphasis lies in establishing tailored regulatory compliance procedures to suit your product portfolio and target markets, providing assistance in:
- Establishing protocols for document control
- Research and development
- Risk management
- Software development
- Supplier assessment
- Oversight of equipment
Businesses involved in the production or distribution of medical devices in the United States are required to annually register with the FDA
Eclevar offers a team of leading experts who excel in navigating the US FDA regulatory process.
- Determination of applicability and FDA registration
- Assignment of management responsibility
- Staff training
- Equipment and facility maintenance
- Review of non-conforming product
- Data retention and control
- 510k clearance
- Premarket Approval
Eclevar’s expertise ensures effective representation to the US FDA, showcasing the scientific validity, safety, and effectiveness of our clients’ technologies.
Medical devices in dentistry – the new MDR regulation
The Medical Device Regulation (MDR 2017/745) replaced the old Medical Device Directive (MDD 93/42/EEC) in European law starting from May 26th, 2021. Medical devices approved under the old directive can continue to be marketed until May 26th, 2025. The MDR emphasizes updated requirements for documentation, post-market surveillance, risk analysis, and traceability of medical devices in the EU/EEA.
EUDAMED and UDI System
Medical devices need to be registered in the European Database for Medical Devices (EUDAMED) using the Unique Device Identification (UDI) system. EUDAMED will be fully operational from May 2022, expanding beyond communication between Competent Authorities to include publicly accessible information.
Dental Device Reimbursement
Medical device reimbursement facilitates patient access to essential medical devices. This process not only guarantees that patients receive necessary treatments but also ensures that medical resources are allocated efficiently.
Eclevar offers strategic, operational consulting, and call center solutions to navigate this process effectively, resulting in a positive and streamlined reimbursement experience for all stakeholders involved. Our comprehensive reimbursement services include:
- Clinical trial reimbursement
- Medical billing and coding
- Medical reimbursement
- Reimbursement resource guides
- Strategic reimbursement
Partner with Eclevar to start a journey of innovation and excellence in Dental Device development
We are dedicated to helping you create dental solutions that improve patient care. Contact us today to discuss how our tailored services can bring your vision to life and make a lasting impact on the field of dentistry.
