AssurX
21 Case Studies
A AssurX Case Study
MIMEDX, a leader in placental biologics, needed a more effective way to manage quality and regulatory compliance as its manual processes and a previous eQMS implementation proved too cumbersome. The company turned to AssurX for an electronic QMS that could better support highly regulated requirements, including GMP, AATB, and ISO 13485 goals.
AssurX implemented a configurable eQMS focused first on nonconformance, CAPA, and deviation management, replacing manual workflows with automated trending, notifications, and reporting. The result was a more user-friendly system with stronger visibility for supervisors and improved efficiency, while AssurX’s responsiveness and configurability helped MIMEDX move forward with a platform built to scale with future quality needs.
Joanne Mowery
Electronic QMS (eQMS) Project Manager