Matrix ReqMatrix One
|
||||||
Related Products
|
||||||
About
Matrix Req (formerly Matrix Requirements) is a collaborative, AI-powered software explicitly built to meet the rigorous needs of medical device development. It helps cross-functional teams design, build, and launch high-quality medical devices while maintaining complete, end-to-end traceability of requirements, risks, and tests. The platform automates the cumbersome audit preparation process by generating structured documentation and trace matrices directly from live data, reducing regulatory submission timelines from weeks to days. Trusted by over 500+ life sciences companies, Matrix Req ensures that compliance is built-by-design rather than treated as an afterthought.
|
About
qmsWrapper is a connected Quality Management System (eQMS) built specifically for medical device startups and SMEs. Instead of implementing a complex enterprise platform from day one, organizations can grow their QMS through three connected editions: Foundation, Lifecycle, and Vigilance.
Foundation helps companies move from paper forms, Word documents, and spreadsheets to controlled documents, workflows, training, and AI-assisted quality processes. Lifecycle adds CAPA, Quality Events, Change Control, Risk Management, Technical File management, Supplier Quality, and Smart Traceability Matrix. Vigilance extends the platform with post-market surveillance, regulatory oversight, audit readiness, and AI governance.
Built for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper helps companies scale their quality system without rebuilding or migrating to another platform.
|
|||||
Platforms Supported
Windows
Supported
Mac
Supported
Linux
Supported
Cloud
Supported
On-Premises
Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Supported
|
Platforms Supported
Windows
Supported
Mac
Supported
Linux
Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
|
|||||
Audience
Medical device companies
|
Audience
Medical Device Companies, MedTech Startups, SaMD, eQMS, ISO 13485, ISO 14971, FDA QMSR, EU MDR, Quality Management, Regulatory Affairs, Quality Assurance, CAPA, Risk Management, Technical File, Traceability
|
|||||
Support
Phone Support
Supported
24/7 Live Support
Supported
Online
Supported
|
Support
Phone Support
Not Supported
24/7 Live Support
Not Supported
Online
Supported
|
|||||
API
Offers API
Supported
|
API
Offers API
Not Supported
|
|||||
Screenshots and Videos |
Screenshots and Videos |
|||||
Pricing
$500 per month
Free Version
Supported
Free Trial
Supported
|
Pricing
€3,499
Foundation starts at €3,499 per year with unlimited users. Lifecycle and Vigilance pricing is available on request. All editions are designed to grow with your quality management needs without requiring migration to a new platform.
Free Version
Not Supported
Free Trial
Supported
|
|||||
Reviews/
|
Reviews/
|
|||||
Pros & Cons from Real UsersPros
Cons
|
||||||
Training
Documentation
Supported
Webinars
Supported
Live Online
Supported
In Person
Supported
|
Training
Documentation
Supported
Webinars
Not Supported
Live Online
Supported
In Person
Not Supported
|
|||||
Company InformationMatrix One
Founded: 2016
United States, Germany, France, Belgium, United Kingdom
matrixone.health/products/matrix-req
|
Company InformationqmsWrapper
Canada
www.qmswrapper.com
|
|||||
Alternatives |
Alternatives |
|||||
|
|
||||||
|
|
||||||
|
|
||||||
Categories |
Categories |
|||||
Requirements Management Features
Automated Functional Sizing
Not Supported
Automated Requirements QA
Not Supported
Automated Test Generation
Not Supported
Automated Use Case Modeling
Not Supported
Change Management
Supported
Collaboration
Supported
History Tracking
Supported
Prioritization
Supported
Reporting
Supported
Status Reporting
Supported
Status Tracking
Supported
Summary Reports
Supported
Task Management
Supported
To-Do List
Not Supported
Traceability
Supported
User Defined Attributes
Supported
|
CAPA Features
Audit Management
Supported
CAPA Planning
Supported
Change Management
Supported
Complaint Management
Supported
Incident Management
Not Supported
Nonconformance Tracking
Supported
Quality Control
Supported
Risk Management
Supported
Root Cause Analysis
Supported
Training Management
Supported
Quality Management Features
Audit Management
Supported
Complaint Management
Supported
Compliance Management
Supported
Corrective and Preventive Actions (CAPA)
Supported
Defect Tracking
Supported
Document Control
Supported
Equipment Management
Not Supported
ISO Standards Management
Supported
Maintenance Management
Not Supported
Risk Management
Supported
Supplier Quality Control
Supported
Training Management
Supported
|
|||||
Integrations
Jira
Supported
Azure DevOps
Supported
Confluence
Supported
GitHub
Supported
GitLab
Supported
Matrix Quality
Supported
|
Integrations
Jira
Supported
Azure DevOps
Not Supported
Confluence
Not Supported
GitHub
Not Supported
GitLab
Not Supported
Matrix Quality
Not Supported
|
|||||
|
|
|