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Build high quality SxMD solutions with MatrixQMS.

Achieve compliance and innovation in your Medical Device with a collaborative solution that bridges the gap between engineering and quality teams.

Trusted by 200+ SxMD & Medical Device Companies

Lean & agile quality management

Take control of your documents, records, CAPAs, training, audits and risk management.

Standards and Procedures

Ensure your project meets regulatory requirements with a flexible software platform that includes ISO 13485.

  • Custom create or access our full library of standards and procedures templates.

  • Easily build your own gap analysis against any standard and link it to the required processes.

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Risk Management aligned with ISO 14971

Implement a risk-based approach with an eQMS that enables you to quickly identify and mitigate risks.

  • Run a risk analysis for your processes in seconds.

  • Efficiently manage risk with an eQMS that connects your quality system and design controls.

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Unify Work Instructions

Support your day-to-day workflow with accurate Work Instructions that keep teams aligned and on track.

  • Quickly record all your technical details for processes.

  • Easy to access and update as your processes evolve.

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Published QMS

Easily create, review, approve and publish quality policies, procedures and work instructions in a centralized location.

  • Ensure alignment with alerts and notifications as versions are modified.

  • Demonstrate your commitment to compliance to internal and external auditors.

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Hear from our customers


“We’ve cut the number of FTEs working on document control tasks by 50%, which frees our employees to focus on value-added activities.”

Umesh Sharma, Head QA/RA, Meril

Core Features

Ensure success with key quality management system capabilities built for SxMD.

CAPAsLog corrective and preventative actions and link them to the task in your issue tracking software.
Gap AnalysisLink regulatory requirements from standards and regulations with your procedures in your QMS.
Document ManagementReview, approve, update, and link documents with full traceability within the platform. No third-party documentation software needed.
Training WorkflowsAssign training and set due dates for individual or role-based training activities.
TemplatesCreate and approve templates in a central place. Assign templates to different projects in QMS and ALM.
Compliant SignaturesRequest and collect compliant 21 CFR Part 11 signatures on any documentation so you can be prepared for your next audit.
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Take a tour with us to see how you can better document requirements, faster with Matrix Requirements.