Top 10 Best Medical Device Manufacturing Erp Software of 2026

Plex is a cloud-native Manufacturing Operations Management (MOM) platform that serves as a comprehensive ERP solution for discrete manufacturers, including medical device production. It provides real-time visibility across the supply chain, production floor, quality control, and compliance processes, with built-in tools for FDA 21 CFR Part 11, ISO 13485, and traceability requirements. The system integrates MES, ERP, QMS, and analytics to streamline operations from planning to shipping, enabling data-driven decisions in regulated environments.

DELMIAworks is a comprehensive ERP solution from Dassault Systèmes, formerly IQMS, designed specifically for discrete manufacturers including medical device companies. It provides end-to-end management of production, quality control, supply chain, inventory, and financials with strong emphasis on regulatory compliance such as FDA 21 CFR Part 11, ISO 13485, and traceability for lots and serial numbers. The platform integrates ERP and MES functionalities for real-time shop floor visibility and efficient operations in highly regulated environments.

QAD ERP is a robust, industry-specific enterprise resource planning solution designed for manufacturing sectors, including medical devices, offering end-to-end management of production, supply chain, and quality processes. It excels in regulatory compliance with built-in support for FDA 21 CFR Part 11, ISO 13485, and Unique Device Identification (UDI) requirements, ensuring traceability from raw materials to finished devices. The cloud-based QAD Adaptive ERP provides real-time visibility, advanced manufacturing execution, and integration capabilities for global operations.

Epicor Kinetic is a cloud-native ERP platform designed for mid-market manufacturers, providing robust tools for production planning, inventory management, supply chain optimization, and quality assurance tailored to regulated industries like medical device manufacturing. It supports critical requirements such as lot and serial number traceability, ISO 13485 compliance, FDA 21 CFR Part 11 reporting, and integrated quality management systems (QMS) to handle CAPA, audits, and non-conformances. With AI-driven insights and modern browser-based UI, it enables real-time visibility and scalability for complex manufacturing operations.

SAP S/4HANA is a next-generation ERP system built on the in-memory HANA database, providing real-time analytics and intelligent automation for enterprise manufacturing, including medical devices. It excels in managing complex supply chains, quality control, batch/lot traceability, and regulatory compliance (e.g., FDA 21 CFR Part 11, ISO 13485, EU MDR) through integrated modules like Quality Management (QM), Materials Management (MM), and Production Planning (PP). The platform supports end-to-end processes from procurement and production to distribution, with AI/ML-driven predictive maintenance and demand forecasting tailored for regulated industries.

Infor CloudSuite Industrial is a cloud-based ERP solution tailored for discrete manufacturers, providing comprehensive tools for production planning, inventory management, quality control, and supply chain operations. It excels in handling complex processes like engineer-to-order and configure-to-order manufacturing, with built-in support for lot/serial traceability, compliance reporting, and regulatory standards such as FDA 21 CFR Part 11 and ISO 13485 relevant to medical devices. The platform integrates MES, APS, and financials for end-to-end visibility, making it suitable for mid-to-large medical device firms navigating regulated environments.

NetSuite is a cloud-based ERP solution from Oracle that delivers comprehensive manufacturing capabilities for medical device producers, including advanced production planning, inventory tracking with lot and serial number control, and quality management tools. It integrates financials, supply chain, CRM, and compliance features to support FDA 21 CFR Part 11, ISO 13485, and other regulatory requirements essential for the industry. With real-time analytics and customizable workflows, it enables efficient operations from design to distribution in complex manufacturing environments.

Microsoft Dynamics 365 is a comprehensive cloud-based ERP platform that unifies finance, supply chain management, manufacturing operations, and CRM functionalities. Tailored for medical device manufacturing, it provides robust lot and serial number traceability, quality management systems compliant with FDA 21 CFR Part 11 and ISO 13485, and production planning tools for regulated environments. It excels in integrating with Microsoft Azure, Power BI, and IoT for real-time analytics and scalable operations across global enterprises.

Acumatica is a cloud-based ERP platform designed for manufacturing, offering modules for production management, inventory control, financials, and CRM. For medical device manufacturing, it provides tools like bill of materials (BOM), shop floor control, lot/serial number traceability, and quality management to support compliance with FDA regulations and ISO 13485. While highly customizable, it excels in discrete manufacturing processes but may require partner extensions for advanced regulatory reporting.

SYSPRO is a comprehensive ERP solution tailored for manufacturing industries, including medical devices, providing end-to-end management of production, inventory, supply chain, and financials. It excels in supporting discrete, process, and mixed-mode manufacturing with robust features for lot/serial traceability, quality control, and regulatory compliance like FDA 21 CFR Part 11 and ISO 13485. The platform offers customizable workflows and real-time visibility to streamline operations in highly regulated environments.