Industry: Medical Devices
Design history files, complaint-to-CAPA chains, and supplier qualification — audit-ready.
ISO 13485, FDA QMSR (21 CFR 820, incorporating ISO 13485:2016 by reference as of Feb 2, 2026), EU MDR, ISO 14971. Structify Industrial connects what your quality team already has across QMS, ERP, and supplier systems and keeps it mapped to the clauses auditors ask about.
Systems we build on
Your stack, not a net-new platform.
SAP QM, Oracle NetSuite, Infor CloudSuite, Dynamics 365, MasterControl, Veeva, Arena PLM
Where hours leak
Medical Devices operators know the week. It looks the same every month.
Where hours leak today
- Design history file integrity depends on manual cross-referencing across QMS instances and document repos.
- Complaint-to-CAPA traceability requires reconstructing chains across facilities before every FDA inspection.
- Supplier qualification under 820.50 lapses go undetected until audit prep surfaces them weeks too late.
- Design control traceability across sites depends on someone manually checking propagation after every change.
What Structify ships
- Audit packet assembly from ERP, QMS, and supplier records with gap detection
- Complaint-to-CAPA chain traceability across facilities and QMS instances
- Supplier qualification monitoring with cert expiry alerts before PO approval
- Design change propagation verification across manufacturing sites
What we ship
Builds we deliver for medical devices shops, on the ERP you already run.
Scope it on your stack.
Bring one audit you're dreading. We'll wire it against your ERP and QMS and hand back a working version.