Case Study: Large Medical Device Company achieves audit-ready compliance and centralized quality control with AssurX

CDMO of Specialized Biomedical Polymers and Additives for Medical Device Application

Large Medical Device Company was operating a shared quality system that wasn’t built for medical device and pharmaceutical-grade compliance, creating audit risk, document-control issues, and training inefficiencies. The company needed a modern EQMS foundation that could support FDA 21 CFR Part 210/211, Part 11, and ISO 13485 requirements, and it chose AssurX for document management and training management.

AssurX implemented centralized Document Management and Training Management to automate imports, secure access, routing, escalations, and compliance tracking across the GMP facility. The result was faster task completion, better data integrity, reduced labor on document handling, and favorable audit outcomes, including successful remote audits and ISO 13485 certification maintained with zero findings.