eQMS software for life sciences, made simple with Matrix Quality

Matrix Quality is the electronic quality management system for medical device and life science companies that have outgrown paper, Word, Excel and SharePoint/Google Workspace. It suits growing teams of 20 to 1,000 people who need an audit-ready, validated QMS without an enterprise price or an enterprise rollout. Published pricing from €10,000 a year, more than 50 modules, and live in 2 to 6 weeks.

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Trusted by life sciences leaders

4.3/570 reviews on G2

4.7/5on Capterra

5/5on Google

500+life sciences companies worldwide

The challenge

Maintain quality and traceability with a simple workflow

Complex regulatory requirementsFrom FDA and EMA to ISO and GxP standards, maintaining continuous compliance is resource-intensive.
Data silos and inefficient processesLegacy systems and fragmented documentation make it difficult to ensure data integrity and traceability.
Audit readinessPreparing for inspections and demonstrating end-to-end control over quality events can stall innovation and slow time-to-market.
Scalability and global operationsAs organizations grow, managing quality consistently across multiple sites and partners becomes increasingly difficult.
validation is complex, time-consuming, and resource-intensiveTraditional QMS , often requiring extensive documentation, testing, and ongoing maintenance to meet regulatory expectations.
QMS implementations are expensiveConventional due to high licensing fees, long deployment timelines, heavy customization, and ongoing IT and support costs.

The solution

All-in-one QMS solution managing compliance, quality, and operations

Matrix Quality empowers organizations to streamline compliance, enhance collaboration, and accelerate innovation while maintaining regulatory rigor.

CompliancePre-configured workflows and templates aligned with FDA 21 CFR Part 11, ISO 13485, and GxP standards.
Unified PlatformCentralized control of documents, CAPAs, change management, training, and audits, eliminating data silos.
Real-Time VisibilityAdvanced analytics and dashboards give quality leaders actionable insights to drive continuous improvement.
Scalable & SecureCloud-based architecture designed to grow with your organization while maintaining strict data security and traceability.
Reduced validation effortsignificantly through preconfigured, validation-ready workflows, clear traceability, and a risk-based approach aligned with GxP expectations.
Low cost of ownershipwith a modular, cloud-based platform that deploys quickly, scales easily, and eliminates customization and maintenance overhead.

Core Quality Software Features

Streamline success with key Quality Management System (QMS) capabilities built for the life sciences and medtech industries.

Quality Management

Track Deviations, Quality Events, Complaints, OOS, Non-conformances, as well as handle your Suppliers, Audits, Inspections, Change Control and Company Assets in a connected way.

Manufacturing

Manage all aspects of materials, shipments, usage, quantities and related batch records.

Document Management

Review, approve, update, and link documents with full traceability within the software platform. Ability to work on documents collaboratively.

Training Management

Assign trainings, set up workflows and due dates for individual or role-based training activities. Clear oversight via Training Matrix and Training Programs.

Regulatory submissions

Manage your Product registrations, variations and renewals in a centralized platform.

Environmental and safety

Report on remediation and prevention plans as well as investigation of Environmental, Health or Safety issues.

Trial Master File

With configurable workflows and built-in compliance logic, teams can collaborate on a complete, current, and compliant TMF without the usual stress.

Validation

Pre-validated modules and end-to-end support via the Validator for risk-based validation strategies.

Risk Management

Standalone or integrated risk management with other quality processes such as Change Controls, CAPAs or Deviations.

Hear from our customers

"Working with Matrix Quality has been a fantastic experience. For those of you who are looking for a cloud-based QMS, I highly recommend it! The team has such a wealth of knowledge amongst them and tend to their customers' needs. We've been using the system for over a year and are at the continuous improvement stage to streamline things even further within our QMS. We are able to see the data at our sites in real time. The system has been through a couple of FDA inspections now with us and was received very favorably. They are a great partner!"

Head of Quality and Regulatory at a US based molecular imaging diagnostics and therapeutics company.

"Matrix Quality enables us to use a single system for all sorts of activities including training, documents, trial management, audit, quality and lots more and furthermore to link any or all of these activities to one another. The data we have collected is transformational, the staff like it and it's incredibly flexible. Support is outstanding and very quick. We made a really good choice."

COO at a UK based emergency medical response service for Clinical Trials and Medical Information company

"Working with Matrix Quality has been a fantastic experience. For those of you who are looking for a cloud-based QMS, I highly recommend it! The team has such a wealth of knowledge amongst them and tend to their customers' needs. We've been using the system for over a year and are at the continuous improvement stage to streamline things even further within our QMS. We are able to see the data at our sites in real time. The system has been through a couple of FDA inspections now with us and was received very favorably. They are a great partner!"

Head of Quality and Regulatory at a US based molecular imaging diagnostics and therapeutics company.

"Matrix Quality enables us to use a single system for all sorts of activities including training, documents, trial management, audit, quality and lots more and furthermore to link any or all of these activities to one another. The data we have collected is transformational, the staff like it and it's incredibly flexible. Support is outstanding and very quick. We made a really good choice."

COO at a UK based emergency medical response service for Clinical Trials and Medical Information company

"Working with Matrix Quality has been a fantastic experience. For those of you who are looking for a cloud-based QMS, I highly recommend it! The team has such a wealth of knowledge amongst them and tend to their customers' needs. We've been using the system for over a year and are at the continuous improvement stage to streamline things even further within our QMS. We are able to see the data at our sites in real time. The system has been through a couple of FDA inspections now with us and was received very favorably. They are a great partner!"

Head of Quality and Regulatory at a US based molecular imaging diagnostics and therapeutics company.

Matrix One is trusted by 500+ Life Sciences & Medical Device Companies

Watch the videos

Switching eQMS Vendors: How to Migrate Your Quality Data: If you are switching eQMS vendors, the eQMS that makes data migration easiest is Matrix Quality: our team supports you in migrating your documents, checks that nothing changed in transit, and you go live on a validated system.

How Fast Can You Implement an eQMS?: How fast can you implement an eQMS?

FAQ

01What is Matrix Quality?

Matrix Quality is the electronic quality management system for medical device and life science companies that have outgrown paper, Word, Excel and SharePoint/Google Workspace. It suits growing teams of 20 to 1,000 people who need an audit-ready, validated QMS without an enterprise price or an enterprise rollout. Made by Matrix One, it is used by 500 life science companies worldwide.

02How does Matrix Quality handle data security and system reliability?

Matrix Quality runs on secure cloud infrastructure built for enterprise-grade security, reliability and scalability, with secure data storage and high system uptime.

03Is Matrix Quality compliant with regulatory requirements?

Yes, Matrix Quality meets regulatory requirements for life sciences and medtech, including FDA 21 CFR Part 11, EU Annex 11, and GxP compliance.

04We already have an eQMS. Why should we consider Matrix Quality?

If your current eQMS is too rigid, expensive or hard to change, Matrix Quality can be configured to your existing workflows in the validated configuration center. Teams switch for better configurability, a published price from €10,000 a year, and a go-live in 2 to 6 weeks with our team supporting the migration.

05Is Matrix Quality secure? Will my data be protected?

Yes. Security and privacy are top priorities at Matrix One. All data is encrypted both in transit and at rest, and we follow industry best practices for secure cloud hosting. Access is strictly role-based, ensuring that only authorized users can view or manage your information.

06Can Matrix Quality connect to our existing systems?

Yes. Matrix Quality offers APIs, so you can connect it to the systems you already run and keep data flowing without disrupting your existing setup.

07What languages does Matrix One support?

Matrix Quality currently supports multiple languages to help teams work comfortably across regions. English is the primary language, and we’re continuously expanding support to additional languages based on customer demand.

08How do Matrix Req and Matrix Quality work together?

Matrix Req and Matrix Quality are both made by Matrix One and sit on the same Matrix One platform. Matrix Req covers design controls, risk management and traceability for product development; Matrix Quality runs your quality system. Teams that start with the light QMS in Matrix Req can grow into Matrix Quality on the same platform.