Dental Devices with Matrix Requirements®
Dental devices products must combine biocompatibility, mechanical durability, and patient-specific customization while adhering to strict regulatory standards. Matrix Requirements® supports the complete development cycle of dental technologies.
Dental Devices are at the heart of Matrix Requirements
Dental Devices enhance oral health and function, covering a wide spectrum from precision implants to orthodontic appliances and everyday dental instruments. These products must combine biocompatibility, mechanical durability, and patient-specific customization while adhering to strict regulatory standards. Matrix Requirements® supports the complete development cycle of dental technologies, enabling teams to ensure quality, compliance, and innovation with confidence:
MDR, 21CFR Part 820 and ISO 13485 Alignment Support: Ensure full compliance with UE, US and global regulatory frameworks for dental devices and quality systems.
Custom and Configurable Device Support: Manage modular designs and patient-specific adaptations with traceable requirements and streamlined documentation workflows.
Biocompatibility and Material Validation: Track materials and coatings used in implants and appliances to support long-term safety and regulatory approvals.
Full Lifecycle Documentation: Maintain traceability from initial concept through clinical evaluation, manufacturing, and post-market activities in a single, integrated platform.
Hear from our customers
Matrix Requirements is super effective at handling the complex relationships between design objects, and its user-friendliness convinced us that we’d found the perfect fit for our quality and requirements management needs.”
Michael Strelow, Quality Manager, ViViRA
