Dental Devices with Matrix Req
Dental devices products must combine biocompatibility, mechanical durability, and patient-specific customization while adhering to strict regulatory standards. Matrix Req supports the complete development cycle of dental technologies.
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The challenge
Dental device development spans a wide spectrum with uncompromising compliance requirements
From precision implants and orthodontic appliances to dental instruments and digital dentistry solutions, dental devices must meet strict biocompatibility, durability, and safety standards — while accommodating an increasing demand for patient-specific customization. Teams must navigate multiple regulatory frameworks across global markets, often with limited resources and growing documentation requirements.
- Biocompatibility and material validation:Every material and coating used in implants and appliances must be fully documented and validated for long-term safety — with no gaps in traceability.
- Patient-specific and modular complexity:Managing custom and configurable device variants while maintaining regulatory compliance adds significant overhead to design control.
- Multi-market regulatory burden:Meeting EU MDR, FDA 21 CFR Part 820, ISO 13485, and device-specific standards simultaneously requires structured, traceable documentation across jurisdictions.
Our solution
A single platform for the full dental device development lifecycle
Matrix Req gives dental device teams a structured environment to manage design control, risk, verification, and documentation from initial concept through clinical evaluation and post-market activities. Whether you're developing implants, orthodontic systems, or digital dentistry tools, Matrix Req adapts to your regulatory pathway and design strategy.
- Maintain full traceabilityfrom design inputs to outputs, verification, and risk controls — across materials, components, and product variants.
- Stay compliantwith EU MDR, FDA 21 CFR Part 820, ISO 13485, and other applicable standards in one platform.
- Manage customization confidentlyfrom standard products to patient-specific configurations — with reusable, traceable design elements.
Core Features
Purpose-built capabilities for dental device development teams.
MDR, 21 CFR Part 820 & ISO 13485 Compliance Support
Ensure 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 Support
Manage modular designs and patient-specific adaptations with traceable requirements and streamlined documentation workflows — maintaining compliance across your full product range.
Biocompatibility & Material Validation
Track 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 Documentation
Maintain 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 Generation
Generate 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
