Medical device ERP software – purpose-built for today’s needs

Track devices, components, and materials across their full lifecycle with complete visibility. Maintain device and batch history records (DHRs) for audits and recalls, and support serial genealogy and lot traceability to ensure full accountability from production through post-market.

Manage serialized devices and lot-controlled materials with clear linkage across production, quality, and orders. Connect serials and lots to every step of the process, enabling faster root-cause analysis and containment to limit the impact of defects, deviations, and recalls.

Reduce risk with validation-ready systems and aligned compliance and financial controls. Maintain electronic records and audit trails in line with FDA 21 CFR Part 11, and support ISO 13485, GMP, and global regulatory requirements across operations.

Capture nonconformances and quality events within controlled workflows. Enforce quality processes directly in ERP, and link issues to production, materials, and orders – maintaining traceability, ensure consistency, and support compliant execution across regulated operations.

Manage corrective and preventive actions within a structured, auditable process. Track root causes, actions, and outcomes, and ensure accountability through to closure, helping reduce recurring issues and maintain compliance across quality and production workflows.

Generate complete device and batch history records (DHRs) across materials, production, and quality events. Compile audit-ready documentation for inspections, recalls, and reporting, and see how each device or batch was built, tested, and released.

Provide a real-time view of regulated inventory across materials and components. Control purchasing, handling, and usage with full visibility, and reduce shortages, excess stock, and the risk of using nonconforming or expired materials in production.

Support discrete and continuous manufacturing processes in one system. Manage multiple production paths and product configurations. And maintain control across device types – from consumables such as syringes and tubing to complex equipment like imaging and monitoring systems.

Link production activity directly to financial results to maintain accurate cost visibility. Track materials, labor, and overhead, and gain insight into margins and operational performance across the device lifecycle and product lines.

Balance capacity across constrained, regulated resources such as cleanrooms, skilled labor, and validated equipment. Respond quickly to changes in demand, priorities, or regulations – improving delivery performance without relying on manual replanning.