NEU!! Entwickelt SxMDs mit einem strukturierten eQMS, einschließlich auditfähriger SxMD-Vorlagen, die an EU- und US-Standards angepasst sind. Mehr Erfahren!

Simplify SxMD compliance

Connect quality and design to centralize your source of truth to pass any audit, compliance or regulatory inspection with confidence.

Trusted by 200+ SxMD & Medical Device Companies

Navigate ISO 13485 with clarity

Demonstrate quality compliance with a robust quality management solution that’s configurable to meet all your needs.

Ensure ISO 14971 compliance

Develop your risk management plan, conduct risk analysis and evaluation and implement risk control measures in one connected platform.

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Centralize training records

Automate training workflows for individuals or groups to ensure teams are trained on the latest standards and requirements and operating compliantly.

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Maintain accurate documentation

Facilitate effective document control like versioning, approval processes, and access control without adding to your workload and easily prove compliance.

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Develop software to meet IEC 62304 and IEC 82304

Ensure the safety and effectiveness of your SxMD product by documenting your development, testing, verification and validation activities in a purpose-built platform.

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Comply with CFR Part 11 with ease

Streamline compliant eSignature collection by automating request workflows and signing directly in Matrix.

Hear from our customers

“With MatrixALM, we get a full audit trail of every action taken, which will in turn help us to demonstrate our clients’ compliance during the regulatory approval process.”

Thomas Gustafsson, Senior Consultant, Spirotronic