Top 10 Best Medical Device Erp Software of 2026

DELMIAworks is a comprehensive ERP solution tailored for discrete manufacturers, with specialized capabilities for the medical device industry, integrating production planning, quality management, supply chain, and financials into a single platform. It excels in regulatory compliance, offering tools for FDA 21 CFR Part 11, ISO 13485, and full lot/serial traceability from raw materials to distribution. The system provides real-time shop floor visibility through its built-in MES, enabling lean manufacturing and rapid response to production demands.

Plex is a cloud-native smart manufacturing platform that serves as an integrated ERP, MES, and QMS solution tailored for medical device manufacturers, providing end-to-end visibility from production planning and inventory management to quality control and regulatory compliance. It excels in real-time traceability, electronic records, and adherence to standards like FDA 21 CFR Part 11, ISO 13485, and GxP requirements. Plex leverages a unified data model to eliminate silos, enabling data-driven decisions and process optimization across the supply chain.

MasterControl is a robust quality management system (QMS) platform tailored for medical device manufacturers, offering ERP-like capabilities through its Manufacturing Excellence suite. It streamlines document control, CAPA, audits, training, complaints, and electronic batch records to ensure compliance with FDA 21 CFR Part 11, ISO 13485, and other regulations. The software integrates quality processes with manufacturing workflows, providing real-time analytics and automation to enhance operational efficiency in regulated environments.

QAD Adaptive ERP is a robust, cloud-native enterprise resource planning solution designed specifically for manufacturing industries, including medical devices, offering end-to-end visibility into production, supply chain, and quality processes. It excels in managing complex regulatory requirements like FDA 21 CFR Part 11, ISO 13485 compliance, lot traceability, and serialization critical for medical device manufacturers. The platform supports global operations with real-time analytics and adaptive manufacturing capabilities to handle volatile demand and supply disruptions.

Epicor Kinetic is a modern, cloud-based ERP platform tailored for manufacturing sectors, including medical devices, providing end-to-end visibility into production, supply chain, and quality processes. It supports critical medical device requirements like FDA compliance, ISO 13485 adherence, lot/serial number traceability, and robust quality management systems. With integrated MES capabilities and AI-driven analytics, it helps manufacturers streamline operations while maintaining regulatory standards.

Infor CloudSuite Industrial is a cloud-based ERP solution tailored for discrete and industrial manufacturing, including medical device production, offering comprehensive tools for production planning, inventory management, quality control, and supply chain optimization. It provides lot and serial number traceability, regulatory compliance support, and real-time shop floor visibility to meet demands of regulated industries. While powerful for complex manufacturing, it often requires configuration to fully align with FDA and ISO 13485 standards specific to medical devices.

SAP S/4HANA is a next-generation ERP suite designed for intelligent enterprise operations, offering comprehensive modules for manufacturing, supply chain, finance, and quality management tailored to regulated industries like medical devices. It provides real-time analytics, AI-driven insights, and built-in compliance tools for FDA 21 CFR Part 11, ISO 13485, and UDI serialization. For medical device companies, it excels in lot traceability, CAPA processes, and integrating with PLM/MES systems to streamline production from design to distribution.

Oracle Fusion Cloud ERP is a comprehensive cloud-based enterprise resource planning solution that integrates financials, supply chain, manufacturing, and procurement modules tailored for complex operations. For medical device companies, it excels in compliance management, lot and serial number tracking, quality control, and regulatory reporting to meet FDA, ISO 13485, and other standards. Its AI-powered analytics and unified platform enable real-time visibility across global operations, making it suitable for scaling medical device production and distribution.

SYSPRO is a robust ERP platform tailored for manufacturing industries, including medical devices, offering end-to-end visibility across supply chain, production, inventory, and quality management. It supports critical medical device requirements like lot/serial traceability, FDA 21 CFR Part 11 compliance, and ISO 13485 quality controls through configurable modules. With its flexible architecture, SYSPRO enables mid-sized manufacturers to handle complex regulatory environments while optimizing operations.

Global Shop Solutions is a comprehensive ERP/MES platform tailored for discrete manufacturing environments, including medical device production, offering modules for quoting, scheduling, inventory management, quality control, and shop floor execution. It provides real-time visibility into operations with a single-database architecture that integrates production planning, material requirements, and compliance tracking. While robust for make-to-order manufacturing, it supports medical device needs through traceability and quality tools but often requires customization for FDA/ISO 13485 specifics.