ERP Software for Medical Devices
Medical device manufacturers must navigate one of the most complex regulatory landscapes in all of manufacturing: FDA 21 CFR Part 820 Quality System Regulation, the EU Medical Device Regulation (MDR 2017/745), FDA Unique Device Identification (UDI) requirements for global device tracking, and post-market surveillance obligations including Medical Device Reporting (MDR). ERP systems in this environment must be deeply integrated with quality management systems, support serialized lot traceability throughout the supply chain, manage engineering change control with regulatory impact assessment, and enable rapid device recall execution.
Compare ERP Systems for Medical Devices
Select up to 4 ERP vendors to compare side by side. Filtered to show systems with strong medical devices capabilities.
Key Challenges for Medical Devices
Maintaining compliance with FDA 21 CFR Part 820 (QSR) and EU MDR 2017/745 quality system requirements while managing rapid product innovation
Managing Unique Device Identification (UDI) assignment, labeling, and submission to the FDA GUDID database for the full product catalog
Controlling engineering changes through a regulatory-aware change management process that assesses 510(k) or PMA impact before implementation
Achieving complete serialized lot traceability from raw material components through finished device distribution to enable effective field safety corrective actions
Managing complex device configuration and bill of materials for combination products, custom implants, and multi-component device systems
Coordinating with contract manufacturers and component suppliers while maintaining quality agreement requirements and incoming inspection workflows
Handling Medical Device Reporting (MDR) and vigilance reporting obligations with device-specific complaint tracking linked to production records
Best Medical Devices ERP for SMBs
Recommended for companies with $10M–$250M revenue and 10–200 employees.
Arena PLM+ERP
mid-rangeCloud-native product lifecycle management and ERP platform purpose-built for medical device and high-tech manufacturers. Unified BOM, quality, and change management in a single validated environment with built-in FDA 21 CFR Part 11 compliance.
Best for: Emerging and growth-stage medical device companies
SYSPRO
mid-rangeManufacturing-focused ERP with strong lot traceability, serial number management, quality inspection, and BOM management for regulated device manufacturers.
Best for: Small to mid-size Class I and Class II medical device manufacturers
Acumatica
mid-rangeCloud ERP with manufacturing, quality management, and lot/serial traceability capabilities adaptable for ISO 13485-compliant quality systems with third-party eQMS integration.
Best for: Growing medical device OEMs with manufacturing and distribution operations
NetSuite
mid-rangeCloud ERP with lot tracking, serial number management, and flexible workflow for medical device companies that need strong financials and inventory alongside basic regulatory document management.
Best for: Early-stage and mid-size medical device companies
Microsoft Dynamics 365 Business Central
mid-rangeCloud ERP with manufacturing and quality modules adaptable to medical device environments with ISV quality management extensions for ISO 13485 compliance.
Best for: Small medical device manufacturers with Microsoft ecosystem investments
QAD Adaptive ERP
premiumManufacturing ERP with deep quality management, lean manufacturing, and compliance tools for medical device manufacturers with strong traceability and validation support.
Best for: Mid-size Class II and Class III medical device manufacturers
Best Medical Devices ERP for Enterprise
Recommended for companies with $250M+ revenue and complex multi-site operations.
SAP S/4HANA
enterpriseEnterprise manufacturing platform with advanced quality management, serialization, and regulatory compliance capabilities for large global medical device corporations managing multi-country regulatory requirements.
Best for: Global medical device corporations with multi-plant, multi-country compliance requirements
Oracle ERP Cloud
enterpriseComprehensive cloud ERP with manufacturing, quality, and supply chain capabilities for large medical device enterprises. Oracle Life Sciences add-ons support regulatory submission and post-market surveillance.
Best for: Large diversified medical device companies seeking cloud transformation
Infor CloudSuite Healthcare
enterpriseHealthcare-specific ERP platform with supply chain and quality management capabilities for medical device manufacturers supplying hospital and health system customers at scale.
Best for: Large device manufacturers with direct health system distribution channels
Microsoft Dynamics 365 Finance & Supply Chain Management
enterpriseEnterprise ERP with advanced manufacturing, quality management, and supply chain capabilities for large medical device organizations operating within the Microsoft ecosystem.
Best for: Large medical device companies leveraging Microsoft Azure and Power Platform
Essential ERP Capabilities for Medical Devices
FDA 21 CFR Part 820 and ISO 13485 quality system management with DHF and DHR support
Unique Device Identification (UDI) assignment, label management, and GUDID submission workflow
Serialized device traceability from component receipt through finished device distribution and implant tracking
Engineering change management with 510(k) and PMA regulatory impact assessment workflow
Device Master Record (DMR) and Device History Record (DHR) management linked to production
Complaint management and Medical Device Reporting (MDR) workflow with CAPA integration
Contract manufacturer and supplier quality management with incoming inspection and material disposition
Field safety corrective action (FSCA) and recall management with complete device location traceability
Multi-level BOM management for combination products and complex device assemblies
Post-market surveillance data collection and trend analysis for regulatory periodic safety reporting
Medical Devices ERP Cost Ranges
SMB
$60,000 – $250,000
10–60 users
Implementation: $75,000 – $350,000
Mid-Market
$250,000 – $1,000,000
60–250 users
Implementation: $300,000 – $1,500,000
Enterprise
$1,200,000 – $8,000,000+
250–3,000+ users
Implementation: $2,000,000 – $12,000,000+
Implementation Considerations
Validate the ERP vendor's experience with ISO 13485 quality system configuration and FDA 21 CFR Part 820 alignment — not all manufacturing ERP vendors have genuine medical device regulatory depth
Plan UDI assignment and GUDID submission workflow design early, as the data requirements (DI, PI, expiration, lot/serial) drive BOM, labeling, and shipping configuration across the system
Engage regulatory affairs in change control workflow design before configuration — engineering change processes that don't reflect the actual regulatory impact assessment methodology will create compliance gaps
Plan DHR (Device History Record) completeness testing as a formal go-live gate — the DHR must capture all production activities, inspections, and signatures required by 21 CFR Part 820.184
Budget for post-go-live validation activities for any system changes — medical device ERP changes that affect regulated records or processes require documented impact assessment, testing, and approval before deployment to production
Frequently Asked Questions
What is FDA 21 CFR Part 820 and how does it affect medical device ERP?
FDA 21 CFR Part 820, the Quality System Regulation (QSR), requires medical device manufacturers to establish and maintain a quality system that ensures the safety and effectiveness of their devices. For ERP systems, this means maintaining Device History Records (DHR) that document all production activities, material lot traceability, inspection results, and electronic signatures for regulated steps. The ERP must also support design history file (DHF) management, corrective and preventive action (CAPA) workflows, and management review data compilation.
What is UDI and how does medical device ERP support it?
The FDA Unique Device Identification (UDI) system requires most medical devices to bear a unique identifier consisting of a Device Identifier (DI) and a Production Identifier (PI). ERP systems support UDI by managing the DI-PI data structure in the item master, generating UDI-compliant barcode labels, capturing lot/serial/expiration data at production, and supporting automated GUDID (Global UDI Database) data submission. UDI also drives traceability requirements — the ERP must link every distributed device to its UDI for recall and adverse event response.
Does a medical device ERP need to be validated?
Yes, for Class II and Class III device manufacturers, ERP systems that create, process, or maintain GMP records are considered part of the quality system and must be validated. This includes installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) testing. The level of validation rigor is risk-based — systems used to create regulated records like DHRs require more extensive validation than general financial modules. Class I manufacturers with limited exemptions may have reduced validation obligations.
What is the difference between 21 CFR Part 820 and ISO 13485?
21 CFR Part 820 is the FDA's Quality System Regulation for medical devices sold in the United States. ISO 13485 is the international standard for medical device quality management systems required for CE marking and sales in the European Union, Canada, Japan, and other markets. The two standards are largely harmonized, but ISO 13485 has some additional requirements around risk management and customer focus. Most global device manufacturers implement a quality system that satisfies both simultaneously.
How does medical device ERP handle field safety corrective actions and recalls?
Medical device ERP recall management uses UDI and lot/serial traceability data to identify all units of a specific device configuration distributed within a defined date range. The system generates distribution lists by customer and location, supports communications tracking, manages customer return authorizations, and documents device disposition (rework, destruction, or return to inventory after correction). Complaint and MDR data linked to the recalled device configuration supports root cause analysis and FDA reporting.
What role does PLM play alongside ERP for medical device manufacturers?
Product Lifecycle Management (PLM) systems manage the design, engineering, and regulatory documentation of a device — including design specifications, risk management files (ISO 14971), verification and validation records, and regulatory submissions. ERP manages production, inventory, and financial operations. PLM and ERP are typically integrated so that approved BOMs, component specifications, and engineering changes flow from PLM to ERP automatically, maintaining consistency between design intent and manufacturing execution.
Which ERP systems are most popular among Class III medical device manufacturers?
SAP S/4HANA is the dominant platform among large Class III device manufacturers (implantables, life-sustaining devices) due to its comprehensive quality management, serialization, and global regulatory capabilities. QAD Adaptive ERP is well regarded in the mid-market for its validated quality management and lean manufacturing tools. Arena PLM+ERP is increasingly adopted by emerging Class II and Class III companies that need integrated PLM and ERP from their earliest commercial stage.
How do medical device companies manage contract manufacturer (CM) quality requirements in ERP?
Medical device ERP manages contract manufacturer quality through supplier quality modules that enforce quality agreements, manage incoming inspection requirements per supplier and component, track non-conformances and CAPAs issued to CMs, monitor supplier scorecards and audit findings, and manage supplier approved manufacturer lists (AML). Purchase order workflows can be configured to block receipt of unqualified material or require incoming inspection completion before lot acceptance.
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