Get your medical device
faster.
Streamline development with a flexible, cloud-enabled solution for complex Medical Devices. Our three core products simplify design control, quality management, and cloud data connectivity for fast certification and global compliance.
Designed by Medical Device experts
Purpose-built software platforms to help you scale, enhance your workflows & cloud data connectivity, and ensure regulatory compliance.
Bridging the gap between software development and regulatory compliance.
R&D
RA/QA
ExecutivesThe Matrix Requirements Platform
Our easy to use, flexible software platform allows all teams to quickly document requirements & become compliant
Matrix ALM
Build regulated software with an agile application lifecycle management tool made for medical devices. Ensure compliance is never a barrier to innovation.
Easily capture all design inputs and outputs
Generate DHF & Technical Files with a few clicks
Traceability across requirements, specs, tests & risks
Compatible with IEC 62304, 62366, ISO 14971 and more!
Matrix QMS
Navigate the complex regulatory landscape with an intuitive and fully customizable quality management system (eQMS).
Ensure compliance and product quality
Quickly write, review, and publish your quality manual
Manage quality records like CAPAs, supplier, audits and more
Full traceability from standards to processes
Galen Cloud
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
HIPAA/GDPR and ISO 13485:2016 Certified
The backbone of medical device design
Learn more from our customers
We are the SxMD solution of choice, helping accelerate speed to market & compliance at 200+ Medical Device companies worldwide
“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
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