FDA-Compliant Manufacturing Software
ISO 13485 and 21 CFR Part 11 compliant manufacturing system with DHF management, device history records, and complete traceability.
Medical Device Compliance
Live Medical Device Production Control Room
Real-time ISO 13485 and FDA 21 CFR Part 11 compliant operations with DHR automation, validation tracking, and complete traceability
Medical Device Production Control Room
ISO 13485 & FDA 21 CFR Part 11 Compliance
Medical Device-Specific Features
DHF Management
Design History File tracking with revision control. Link design documents to production records. Complete traceability.
Device History Records
Automated DHR generation for every device. Serial and lot traceability. Material certification links.
Validation Support
IQ/OQ/PQ documentation. Change control workflows. Validation protocols and reports built-in.
Electronic Signatures
21 CFR Part 11 compliant e-signatures. Multi-level approval workflows. Complete audit trails.
CAPA Management
Corrective and preventive action tracking. Root cause analysis. Link CAPAs to production records.
Complaint Handling
Medical device complaint management. MDR reporting support. Investigation workflows and documentation.
Medical Device Success Story
"MonitorZ transformed our FDA compliance. The DHR automation and electronic signatures saved us weeks during our last audit. The system is 21 CFR Part 11 compliant out of the box."
Ready for FDA-Compliant Manufacturing?
See how MonitorZ supports medical device manufacturers with ISO 13485 and 21 CFR Part 11 compliance.