Skip to content 
Medical device manufacturers face unparalleled regulatory pressure; from FDA compliance and ISO 13485 certification to complete product traceability and rigorous quality control. Every batch, every component, every process step must be documented, validated, and audit-ready.
Syspro’s purpose-built ERP for medical device manufacturing gives you intelligent automation and real-time visibility across design, manufacturing, distribution, and service operations. Because of Syspro, Class I and II device manufacturers maintain compliance, accelerate time to market, and deliver life-changing products with confidence—knowing every detail is tracked, controlled, and documented.
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 control modules with electronic signatures, automated audit trails, and non-conformance tracking ensure FDA 21 CFR Part 11 and ISO 13485 compliance through our ISO compliance solution. Every transaction is validated, documented, and traceable—giving you confidence during audits and inspections.
Lot and Serial Traceability
Comprehensive lot and serial number tracking provides complete genealogy from component receipt through finished device distribution. Quickly identify affected batches during quality events, execute targeted recalls, and maintain device history records (DHR) with precision.
Engineering Change Control
Maximize quality control by tracking products, materials, and processes throughout your entire operation. The Quality Assurance module assists with quality inspections when receiving items from suppliers or from work-in-progress (WIP), ensuring that all materials meet your standards before moving further in the process. This capability not only facilitates effective recalls when defects are identified, protecting customers and maintaining compliance with industry regulations, but also helps prevent issues before they reach later stages of production.
Advanced Production Management
Real-time shop floor control with electronic batch records, in-process quality checks, and material validation ensures every device meets specifications. Manufacturing operations management (MOM) capabilities give you visibility and control over every production step.
Intelligent Supply Chain Visibility
Supplier quality management, preferred supplier tracking, and material planning optimization keep your supply chain flowing smoothly. AI-powered insights identify potential disruptions before they impact production, while automated procurement maintains optimal inventory levels.
Service & Warranty Management
Complete field service management tracks device maintenance, repairs, and warranty claims throughout the product lifecycle. Monitor warranty costs, manage replacement inventory, and maintain service records that satisfy regulatory requirements while improving customer outcomes.
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.