Compliance & Certifications
At Matrix One, compliance isn't an afterthought, it's at the core of everything we do.
From design to deployment, every step of our process is shaped by internationally recognized standards for security, quality, and data integrity.
Our products have successfully completed rigorous third-party audits and maintain industry-leading certifications. These validations confirm what our customers already know: Matrix One is a partner you can trust.
Matrix Req
Built for precision. Certified for compliance.
Engineered to support product development in regulated industries, Matrix Req upholds the highest standards of quality management and information security.
ISO 13485:2016 Certified
Independently certified to ISO 13485:2016 for medical device quality management, ensuring complete traceability, risk management, and documentation control across the entire product lifecycle.
ISO/IEC 27001:2022 Certified
Independently certified to ISO/IEC 27001:2022 for information security management, safeguarding design and product data with robust controls aligned to international best practices.
Matrix Connect
Built for connection. Certified for protection.
Designed to connect teams, data, and systems across the life-sciences ecosystem, Matrix Connect delivers enterprise-grade compliance and protection.
ISO 13485:2016 Certified
Independently certified to ISO 13485:2016, demonstrating our continued commitment to consistent, safe, and high-quality processes for connected medical device workflows.
HITRUST CSF Certified
Validated against the most comprehensive security framework in healthcare, covering HIPAA, NIST, and ISO requirements — ensuring data privacy and protection at every level.
Matrix eIFU
Built for clarity. Certified for quality.
Designed to manage and publish electronic Instructions for Use in highly regulated environments, Matrix eIFU ensures controlled, reliable, and compliant delivery of critical product information.
ISO 9001:2015 Certified
Independently certified to ISO 9001:2015 for quality management, demonstrating robust processes for consistency, reliability, and continual improvement in the creation and distribution of eIFU content.
Matrix Quality
Built for excellence. Certified for consistency.
Designed to streamline quality management and operational workflows, Matrix Quality empowers organizations to maintain the highest levels of process integrity and performance.
ISO 9001:2015 Certified
Independently certified to ISO 9001:2015 for quality management, demonstrating our commitment to operational excellence, customer satisfaction, and a culture of continuous improvement across all business processes.
Compliance is more than a requirement, it's a competitive advantage. By aligning with globally recognized frameworks, Matrix One enables its customers to:
Accelerate regulatory submissions and audits.
Reduce operational risk and ensure data integrity.
Gain confidence that every workflow meets the highest standards.
With Matrix, you're not just compliant. You're ahead of the curve.