Design-Connect-Launch
your medical devicewith our all in one solution
Streamline development with a flexible, cloud-enabled solution for complex Medical Devices. Our two core products simplify design control, quality management, and cloud data connectivity for fast certification and global compliance.
Our Software Suite
Matrix Requirements
The best design control & eQMS software for medical devices companies.
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Matrix Connect
The all-in-one cloud connectivity solution for medical device companies.
Jump to Connect
Our Key Features
Matrix Requirements provides Medical Device companies with software to help them achieve compliance, reduce risks, offer connectivity.
Matrix Requirements
Build regulated software with an agile application lifecycle management tool made for medical devices. Ensure compliance is never a barrier to innovation with a fully customizable quality management system (eQMS) module. Compatible with IEC 62304, 62366, ISO 14971 and more!
Capture all design inputs and outputs
Generate DHF & Technical Files with a few clicks
Ensure traceability across requirements, specs, tests & risks
Write, review, and publish your quality manual
Manage quality records like CAPAs, supplier, audits and more
Matrix Connect
Centralize data and leverage cloud technologies with our turn-key, configurable, scalable, and easy-to-use platform. Focus on medical innovation without needing to become experts in software design, data storage infrastructure, cyber-security and global regulations.
Collect and securely store data
Visualize and analyze patient and device data
Ensure FDA and global regulatory compliance (IEC 62304, ISO 14971 and more!)
Certify under HIPAA/GDPR, ISO 13485:2016 and HITRUST
Learn more from our customers
Since our foundation in 2014, we have helped hundreds of Medical Devices Companies across their entire journey, from requirements management to product clearance and audit.
“With workflow automation we can import thousands of test cases from our third-party provider 95% faster than if we were performing the same work by hand.”
Jeff Miller, VP of Engineering
"With automation from MatrixALM, we reduced our human resource requirements by two full-time equivalents, while reducing regulatory timeline by 6 months"
Jon Giambattista, Director of Software
“I think VIPUN Medical has easily saved six months by working with Matrix Requirements to create efficient digital workflows.”
Carl Van Lierde, VP Product Development
“With the Matrix Requirements solutions, all employees enjoy access to up-to-date information, helping us to manage regulatory activities effectively.”
Carl Van Lierde, VP Product Development
“The time we saved was the most critical aspect of working with Matrix Connect. It would have been at least six months building cloud connectivity from scratch.”
Greg O'Grady - Co-Founder and CEO, Alimetry
“On top of them having the best solution in the industry, with Matrix Connect, for me, it's the people. They have built trust with our team, I trust them, and that is invaluable for us."
Emily Granger - Senior Marketing Officer, Delphi
