MCRA's consultants are experts in achieving success with international regulatory bodies. Our team has industry leading experience with global regulatory strategy and deep understanding of the medical device lifecycle. We provide assistance through the developmental process, including conception and design considerations, pre-clinical and clinical testing, regulatory application through clearance/approval, and commercialization. Providing clients with the best-in-class representation to regulatory agencies by demonstrating the science, safety, and efficacy of their technologies.
Contact a Dental International Regulatory Expert
Dental Experience
MCRA's team has successfully navigated hundreds of international regulatory submissions. Our capabilities extend 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 medical devices across the industry. MCRA is a world-class provider of regulatory strategy and advice for dental devices, including:
- Additive Manufactured Dental devices (e.g., customized Implants, Crowns, Plates, Dentures, Restorations etc.)
- Bone Grafts
- Bone Substitutes
- Dental Abutments
- Dental Amalgams
- Dental Cements
- Dental Combination Products
- Dental Imaging Equipment
- Dental Implants
- Dental Membranes
- Dental Plates
- Intraosseous Fixations
- Lasers
- Mandibular Condyle Prostheses
- Maxillofacial Reconstruction Implants
- Orthodontic Appliances
- OTC Denture Cushions
- Total Temporomandibular Joint Prostheses
- Transmandibular Implants
International Regulatory Services
MCRA has industry leading specialization in the full spectrum of dental medical devices. Over the years, we have supported hundreds of clients seeking regulatory designations, clearances, and international registrations with Technical files, Dossiers and CERs in OUS markets.
- 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)
Contact a Dental International Regulatory Expert