Quality Management & Compliance for Medical Device Manufacturing
“AssurX is the most flexible and intuitive solution on the market. It is also the most user-friendly from both the end user and administrative perspective. AssurX is 5–10 years ahead of their competitors.”
Enterprise-Wide Quality Management Made for Medical Device Compliance
“The team at AssurX was fantastic throughout the design, implementation, and launch of our QMS system.”
Quality Management Built for Medical Device Regulatory Compliance
AssurX Quality Management System Software Features
The AssurX platform offers an easy-to-use, flexible, integrated system of quality management solutions
that are designed for FDA and EU MDR regulated companies.
One QMS Platform Delivers Every Solution for Medical Device Manufacturing
“The system was deployed under budget and ahead of schedule.”
“For us the benefit of using AssurX is the audit trails, electronic signatures and workflow control. Before AssurX our processes didn’t move. AssurX enables us to know who is doing what, and when they need to have it done.”
– LiseAnn Bailey, Global Cardiac
Assist Device Manufacturer
“To effectively and efficiently manage a significant volume of regulatory documentation…you need a reliable and highly configurable system to meet that challenge.”
“With AssurX, we have significantly improved our efficiency and productivity.”
“We felt AssurX’s ease of configurability allowed us to continue to adapt our processes and solutions to Genzyme’s increasing product portfolio, facilities and international markets.”