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.
The challenge
Our solution
Core Features
Purpose-built capabilities for dental device development teams.
MDR, 21 CFR Part 820 & ISO 13485 Compliance SupportEnsure full compliance with EU, US, and global regulatory frameworks for dental devices and quality systems — with structured workflows, documentation, and traceability built for regulatory submissions.
Custom & Configurable Device SupportManage modular designs and patient-specific adaptations with traceable requirements and streamlined documentation workflows — maintaining compliance across your full product range.
Biocompatibility & Material ValidationTrack materials and coatings used in implants and appliances to support long-term safety, biocompatibility requirements, and regulatory approvals — with full traceability across all design elements.
Full Lifecycle DocumentationMaintain traceability from initial concept through clinical evaluation, manufacturing, and post-market activities — in a single, integrated platform that keeps your design history always current and audit-ready.
Technical Documentation GenerationGenerate audit-ready technical files automatically from your live project data in PDF, Word, or HTML ready for regulatory submissions at any stage of development.
Hear from our customers
With Matrix Req, we avoid all the challenges of using manual or custom-developed tools. Instead, we get a purpose-built solution that’s designed by medical device experts, enabling much faster ISO 13485 compliance.”
François Audéon, Chief Technology Officer
Matrix One is trusted by 500+ Life Sciences & Medical Device Companies
