Medical device manufacturers operate under some of the strictest regulations in the world, from FDA requirements and GMP to ISO 13485 certification. Every batch, component, and process step must be documented, validated, and audit-ready.
Syspro’s ERP for medical device manufacturing gives you intelligent automation and real-time visibility across design, production, distribution, and service so you can maintain compliance, accelerate time-to-market, and deliver safe, life-changing products with confidence.
Navigate FDA 21 CFR Part 11, GMP, and ISO 13485 requirements with integrated electronic signatures, automated audit trails, and complete traceability from raw materials to finished devices through our ISO compliance solution. Because of Syspro, you’re always audit-ready with validated processes and documentation.
Streamline design controls, engineering changes, and production workflows to bring innovative devices to market faster. Intelligent automation reduces manual tasks while maintaining the stringent quality standards your patients depend on.
Track every component, lot, and serial number throughout the entire product lifecycle, from supplier receipt through manufacturing, distribution, and field service with comprehensive medical device traceability capabilities. Respond instantly to quality issues or recalls with complete visibility into where every device is and who received it.
Gain real-time visibility into supplier quality, material availability, and procurement workflows. Build stronger supplier relationships while ensuring critical components meet specifications and arrive exactly when your production schedule demands them.
Manage complex equipment maintenance, repair, and overhaul (MRO) operations with precision. Monitor warranty costs, track replacement items, and maintain service history records that satisfy regulatory requirements while improving customer satisfaction.
Whether you’re manufacturing Class I diagnostic devices or Class II surgical instruments, Syspro’s flexible ERP solution for medical device manufacturing grows with your business. Add capabilities, integrate partners, and expand to new markets—all while maintaining compliance and operational excellence.
Quality Management & Compliance
Built-in quality modules with electronic signatures, audit trails, and non-conformance management help you comply with FDA 21 CFR Part 11 and ISO 13485. Every transaction is validated, documented, and traceable, giving you confidence during audits and inspections.
Lot and Serial Traceability
Comprehensive lot and serial tracking provides full genealogy from component receipt through finished device distribution. Generate complete device history records (DHR) for any device and execute rapid, targeted recalls when required.
Engineering Change Control
Structured workflows, approval routing, and effective-date controls manage the entire ECO lifecycle. You can update designs and BOMs while maintaining full revision history and ensuring only approved specifications are used in production, supporting design control compliance.
Advanced Production Management
Advanced Production Management
Real-time shop floor control, electronic batch records, in-process quality checks, and material validation ensure every device meets specification. Manufacturing Operations Management (MOM) provides end-to-end visibility into each production step.
Intelligent Supply Chain Visibility
Supplier quality management, preferred supplier programs, and optimized material planning keep inventory at the right levels. AI-powered insights highlight potential disruptions before they affect production.
Service & Warranty Management
Field service management tracks maintenance, repairs, and warranty claims across the product lifecycle. You can monitor warranty costs, manage replacement inventory, and maintain complete service records for compliance and better patient outcomes.
Syspro logs every user action with time stamps and user identification, creating an immutable record that supports FDA 21 CFR Part 11. Validation documentation and control frameworks are designed for regulated environments, helping you pass inspections with confidence.
Comprehensive reporting and analytics provide batch records, quality metrics, supplier performance, and traceability documentation for regulatory submissions. Advanced BI tools help you analyze trends and demonstrate ongoing process control.
Robust integration capabilities connect Syspro with LIMS, quality management systems, and other specialized medical device software, whether deployed on-premise or in the cloud. This creates a unified digital ecosystem that maintains data integrity and compliance across all operations.
Syspro provides built-in electronic signature capabilities, automated audit trails, and comprehensive transaction tracking that satisfy FDA 21 CFR Part 11 requirements. Every user action is logged with time stamps and user identification, creating an immutable record of all system activities. Our validation documentation and compliance controls are designed specifically for regulated industries, giving you confidence during FDA inspections.
Yes. Syspro’s comprehensive traceability system tracks serial and lot numbers at every stage, from component receipt through production, packaging, distribution, and field service. You can instantly generate complete device history records (DHR) showing every component, process step, and quality check for any finished device. This bi-directional traceability enables rapid, targeted responses to quality events or recalls.
Syspro’s Engineering Change Control module manages the complete ECO lifecycle with structured workflows, approval routing, and effective date controls. You can implement design changes, update bills of materials, and transition production, all while maintaining complete revision history and ensuring only approved specifications are used. The system prevents unauthorized changes and maintains compliance with design control requirements.
Syspro includes comprehensive reporting services with pre-built regulatory reports and customizable analytics dashboards. Generate batch production records, quality metrics, supplier performance reports, and traceability documentation required for regulatory submissions. Advanced business intelligence tools help you analyze trends, identify improvement opportunities, and demonstrate ongoing process control to regulatory agencies.
Yes. Syspro’s digital platform includes robust integration capabilities that connect with LIMS, quality management systems, and other specialized medical device software. Whether deploying on-premise or in the cloud, Syspro can exchange data with business partners, testing labs, and regulatory systems, creating a unified digital ecosystem that maintains data integrity and compliance across all operations.
Syspro’s flexible platform scales from simple Class I devices to more complex Class II products requiring extensive documentation and quality controls. Configure quality management, traceability, and production workflows to match your specific device classification and regulatory requirements. As your product portfolio evolves or you develop higher-classification devices, Syspro grows with you, adding capabilities without disrupting existing operations.