Medical Devices ERP: Master Compliance and Accelerate Growth
The AI-Enhanced ERP built for the unique demands of medical device manufacturing. Achieve end-to-end traceability, streamline validation, and ensure audit-readiness.
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Navigate Complexity with a Purpose-Built ERP
In the medical device industry, there is no room for error. You face intense regulatory scrutiny, complex global supply chains, and the constant pressure to innovate while maintaining the highest quality standards. Generic ERP systems fail to address these critical needs, leaving you with compliance gaps, inefficient processes, and disconnected data. ArionERP is engineered specifically for medical device manufacturers, providing an integrated, AI-enhanced platform to manage your entire lifecycle. From R&D and clinical trials to manufacturing and post-market surveillance, our solution ensures data integrity, enforces compliance, and provides the operational control you need to bring safe, effective products to market faster.
Your Partner in Quality, Compliance, and Growth
Choosing an ERP is more than a software decision; it's a strategic partnership. We provide the technology and expertise to turn your regulatory burdens into a competitive advantage.
Compliance-Ready Core
Our system is built with features that support FDA 21 CFR Part 11, ISO 13485, and MDSAP requirements, including electronic signatures, audit trails, and robust security controls.
Full Lifecycle Traceability
Gain complete, forward-and-backward traceability of every component, lot, and serial number from supplier to patient, ensuring rapid recall readiness and UDI compliance.
Streamlined Validation
Accelerate your Computer System Validation (CSV) with our comprehensive validation documentation packages and expert guidance, reducing the time and cost to go-live.
Expert-Led Implementation
Our team isn't just software experts; they are medical device industry veterans who understand your unique processes, from design controls to Device History Records (DHRs).
Scalable Architecture
Whether you're a startup launching your first device or an established enterprise expanding globally, our platform scales with you, supporting growth without compromising performance.
AI-Powered Insights
Leverage artificial intelligence for predictive maintenance on equipment, demand forecasting, and identifying quality trends before they become critical issues.
Integrated Quality Management
Manage CAPAs, non-conformances (NCMRs), complaints, and supplier quality directly within your ERP, creating a single source of truth for your QMS.
End-to-End Supply Chain Control
Optimize inventory, manage complex supplier requirements, and gain real-time visibility into your entire supply chain to prevent stockouts and reduce costs.
Dedicated Long-Term Partnership
We provide continuous support, updates, and strategic guidance to ensure your ERP evolves with your business and the ever-changing regulatory landscape.
An Integrated Solution for the Entire Device Lifecycle
ArionERP provides a comprehensive suite of modules, meticulously designed to address the specific operational and regulatory challenges of the medical device industry. Our platform eliminates data silos, providing a unified view of your entire organization.
Inventory Management with UDI & Lot Control
Maintain precise control over your inventory with granular tracking of lots, serial numbers, and expiration dates. Our system is designed for seamless UDI (Unique Device Identification) management, ensuring compliance with global regulations and enabling instant traceability.
- Automate UDI generation, labeling, and submission to regulatory databases like GUDID.
- Enforce FIFO/FEFO picking rules to minimize waste from expired products.
- Manage inventory across multiple warehouses, including consigned and field-service stock.
Manufacturing & Shop Floor Control (eDHR)
Transition to a paperless manufacturing environment with electronic Device History Records (eDHR). Enforce quality checks, capture data in real-time, and maintain a complete, auditable record of your entire production process, from work order release to finished device.
- Digitize work instructions and enforce sequential operations on the shop floor.
- Capture electronic signatures for approvals and quality checks, ensuring 21 CFR Part 11 compliance.
- Track labor, machine time, and material consumption for accurate product costing.
Integrated Quality Management (QMS)
Embed quality into every process. Our integrated QMS module allows you to manage key quality events directly within the ERP, linking them to specific products, lots, suppliers, and manufacturing orders for a holistic view of your quality landscape.
- Manage Corrective and Preventive Actions (CAPA) from initiation to closure.
- Track and resolve non-conformances (NCMRs) and customer complaints efficiently.
- Automate supplier scorecards based on performance, delivery, and quality data.
Regulatory & Compliance Reporting
Generate accurate and timely reports required by regulatory bodies. Our system centralizes the data you need for audits, submissions, and post-market surveillance, dramatically reducing manual effort and the risk of errors.
- Create comprehensive traceability reports in minutes for mock recalls or audits.
- Maintain and report on training records to ensure personnel are qualified for their roles.
- Generate adverse event reports and manage post-market surveillance activities.
Procurement & Supplier Management
Ensure the quality and integrity of your supply chain. Manage your Approved Supplier List (ASL), track supplier certifications, and automate purchasing based on production demand and inventory levels, all while maintaining a complete audit trail.
- Enforce purchasing only from approved suppliers for specific components.
- Track supplier performance with scorecards for on-time delivery, quality, and cost.
- Manage purchase requisitions, purchase orders, and receiving with integrated quality inspections.
Sales, Order & Service Management
Streamline your entire order-to-cash process. Manage complex pricing, track sales commissions, and handle device servicing and repairs with full visibility into product history and customer interactions.
- Manage sales orders, RMAs (Return Material Authorizations), and service contracts.
- Track consigned inventory at hospitals or distributor locations accurately.
- Provide field service technicians with mobile access to device history and service protocols.
Financial Management & Costing
Gain a clear, real-time view of your company's financial health. Our robust accounting module provides accurate product costing, detailed financial reporting, and seamless integration with all operational modules.
- Utilize standard, actual, or average costing methods to understand true product costs.
- Automate accounts payable, accounts receivable, and general ledger functions.
- Generate financial statements and performance reports compliant with GAAP/IFRS.
Product Lifecycle Management (PLM) Integration
Bridge the gap between engineering and manufacturing. Our ERP seamlessly integrates with leading PLM systems to ensure that Bills of Materials (BOMs), item masters, and engineering changes are synchronized and accurate across the organization.
- Automate the transfer of design data to manufacturing, reducing manual entry errors.
- Ensure manufacturing is always working with the latest approved revision of a product.
- Link the Device Master Record (DMR) to the Device History Record (DHR) for complete lifecycle visibility.
Engineering Change Management
Manage product changes in a controlled and compliant manner. Our Engineering Change Order (ECO) functionality ensures that all changes are properly reviewed, approved, documented, and implemented across all affected departments.
- Create automated workflows for change request submission, review, and approval.
- Assess the impact of changes on inventory, open orders, and production schedules.
- Maintain a complete, auditable history of every change to a product or process.
Document Control & Management
Centralize and control all critical documents for your QMS. Manage SOPs, work instructions, and specifications with version control, approval workflows, and electronic signatures to ensure everyone is using the correct, current documents.
- Enforce periodic review cycles and manage document obsolescence.
- Link documents directly to parts, processes, or training requirements within the ERP.
- Provide a secure, auditable repository for all controlled documentation.
Human Resources & Training Records
Ensure your team is competent and qualified. Manage employee roles, responsibilities, and training records directly within the ERP. Link training requirements to specific processes or equipment to enforce compliance.
- Automate notifications for required or expiring training certifications.
- Maintain a complete training history for each employee, ready for audit review.
- Restrict access to certain operations until required training is completed.
CRM for Healthcare Professionals
Manage relationships with surgeons, hospitals, and distributors. Our integrated CRM tracks communications, manages sales pipelines, and provides a 360-degree view of your customer interactions, all linked to sales and service history.
- Track product evaluations, sample requests, and sales activities with key opinion leaders.
- Manage contracts and pricing agreements with Group Purchasing Organizations (GPOs).
- Log and manage customer feedback and complaints, feeding directly into the QMS module.
Business Intelligence (BI) & Analytics
Turn your operational data into actionable insights. Our BI and analytics tools provide real-time dashboards and reports on key performance indicators (KPIs) across manufacturing, quality, finance, and sales.
- Monitor production yields, scrap rates, and overall equipment effectiveness (OEE).
- Analyze sales trends by product, region, or healthcare provider.
- Create custom dashboards to track the metrics that matter most to your business.
Field Service & Equipment Tracking
Manage the entire lifecycle of capital equipment installed at customer sites. Schedule preventive maintenance, dispatch technicians, and track service history for each serialized device to ensure uptime and customer satisfaction.
- Provide mobile access for field technicians to view service history and log work orders.
- Manage service parts inventory and track usage for repairs.
- Bill for service calls, contracts, and spare parts accurately.
AI-Powered Predictive Analytics
Move from reactive to proactive operations. Our AI engine analyzes historical data to forecast future outcomes, helping you make smarter, data-driven decisions that improve quality, reduce costs, and enhance supply chain resilience.
- Predict potential quality failures based on manufacturing process data.
- Forecast customer demand more accurately to optimize inventory levels.
- Identify suppliers at risk of delivery delays based on past performance and external factors.
Success Stories in Medical Device Manufacturing
See how we've helped companies like yours overcome compliance hurdles and achieve operational excellence.
The Challenge: Building a QMS from Scratch
The client was using spreadsheets and manual documents to manage their design controls, purchasing, and early-stage production. This approach was not scalable, prone to error, and would not pass a regulatory audit. They needed a single system to act as the backbone of their new Quality Management System.
Key Challenges:
- Lack of a centralized document control system.
- No formal process for supplier qualification or purchasing controls.
- Inability to create and manage Device History Records (DHRs).
- Absence of auditable training records for employees.
Our Solution: A Phased, Compliance-First Implementation
We implemented ArionERP's core modules with a focus on establishing compliant processes first:
- Document Control & Training: Deployed the document control module to manage SOPs and the HR module to track training records.
- Supplier & Purchasing Controls: Established the Approved Supplier List (ASL) and implemented a formal PO and receiving inspection process.
- Manufacturing & eDHR: Configured BOMs, routings, and electronic DHRs for their pilot production runs.
- Audit-Ready Reporting: Provided training on how to pull traceability and compliance reports for their upcoming audit.
The Challenge: Disconnected Inventory and UDI Chaos
Each facility used its own system, leading to a lack of visibility into total inventory. Tracking serialized implants and instrument kits sent to hospitals was a manual, error-prone process, making UDI compliance and inventory reconciliation nearly impossible.
Key Challenges:
- No single source of truth for global inventory.
- Difficulty tracking consigned inventory and surgical kit components.
- High risk of shipping expired products.
- Manual and inefficient UDI data management process.
Our Solution: A Unified, UDI-Centric Platform
We implemented ArionERP across all three sites to create a single, unified system:
- Centralized Inventory: Consolidated all inventory data, providing real-time visibility into stock levels at each location, including consigned stock.
- Serialized Kit Management: Implemented advanced logic to track serialized implants within reusable instrument kits, simplifying surgical case management.
- Automated UDI Compliance: Integrated with GS1 standards to automate UDI generation and labeling at the point of manufacture.
- Mobile Warehouse Operations: Deployed mobile barcode scanners to streamline receiving, picking, and shipping, ensuring data accuracy.
The Challenge: A Brittle Legacy System Stifling Growth
The old ERP was a patchwork of customizations that was difficult to maintain and validate. It couldn't support multi-currency and multi-language requirements for global operations, and financial consolidation was a painful manual process each month.
Key Challenges:
- High cost of ownership for the legacy system.
- Inability to get a consolidated view of global financials and operations.
- Compliance risks due to an unsupportable and difficult-to-validate system.
- Lack of real-time data for strategic decision-making.
Our Solution: A Global, AI-Enhanced ERP Rollout
We executed a global rollout of ArionERP, replacing the legacy system with a modern, standardized platform:
- Multi-Company & Multi-Currency: Configured a single instance of ArionERP to manage all global entities, automating financial consolidations.
- Validated Platform: Provided a fully validatable, off-the-shelf solution, dramatically reducing their compliance burden.
- AI-Powered Forecasting: Implemented our AI module to improve demand forecasting for their reagents, reducing stockouts and excess inventory.
- Integrated BI & Analytics: Deployed real-time dashboards for executives to monitor global KPIs for sales, production, and finance.
Our Proven Path to a Compliant Go-Live
We follow a structured, risk-based implementation methodology designed to ensure your project is delivered on time, on budget, and is fully compliant with regulatory requirements.
1. Discovery & Planning
We start by deeply understanding your processes, user requirements (URS), and compliance needs. We create a detailed project plan and a validation plan (VP) that will guide the entire implementation.
2. Configuration & Development
Our team configures ArionERP to match your specific workflows. Any necessary customizations are developed following GAMP 5 principles, ensuring they are documented and testable.
3. Data Migration
We execute a carefully planned data migration strategy to move your critical data from legacy systems into ArionERP, including data verification and cleansing steps to ensure integrity.
4. Testing & Validation (IQ/OQ/PQ)
This is the most critical phase. We assist your team in executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) test scripts to formally verify and document that the system meets all requirements.
5. Training & Go-Live
We conduct comprehensive training for all users based on their roles. After a final readiness assessment, we manage the go-live process, providing intensive on-site or remote support to ensure a smooth transition.
6. Post-Launch Support
Our partnership doesn't end at go-live. We provide ongoing support, system monitoring, and guidance on maintaining the validated state of your system through future updates and changes.
Built on a Secure and Scalable Technology Stack
ArionERP leverages modern, enterprise-grade technologies to deliver a reliable, secure, and high-performance platform that integrates seamlessly into your existing IT landscape.
What Our Clients Say
"The level of detail in ArionERP's traceability module is incredible. We can trace a single screw from the supplier lot to the exact surgical kit it was placed in. This has given our quality team and our customers complete peace of mind."
"Preparing for FDA audits used to take weeks of gathering paper records. Now, with ArionERP's eDHR and document control, we can pull any record the auditor asks for in seconds. It's a game-changer for our regulatory team."
"As a CFO, I need accurate product costing. ArionERP connects the shop floor data directly to our financials, so I know the true cost of every device we make. The financial visibility is unparalleled compared to our old system."
"Their implementation team understood our unique challenges with sterile disposables and expiration date management. They weren't just software installers; they were true partners who configured the system to perfectly match our business."
"The integrated CAPA module has been fantastic. We can link a corrective action directly to a non-conformance, a supplier, and a specific production lot. It connects all the dots for us and makes our quality process so much more robust."
"We are a small but growing company. ArionERP provided an affordable, scalable solution that gives us the same capabilities as the big players. It's a platform we know we can grow with for years to come."
Frequently Asked Questions
No ERP software itself can be "validated" out of the box. Validation is the process by which a medical device manufacturer demonstrates that the software is suitable for its intended use within their specific quality system. However, ArionERP is designed to be "validatable." We provide features that support compliance, such as electronic signatures for 21 CFR Part 11, comprehensive audit trails, and granular security controls. Crucially, we also provide a comprehensive validation accelerator package with IQ/OQ/PQ templates and expert guidance to significantly reduce the time, cost, and effort of your validation project.
ArionERP supports fully electronic Device History Records (eDHRs). As a product moves through the manufacturing process, the system automatically compiles a complete history, including materials used (with lot numbers), operations performed, personnel involved (with electronic signatures), quality checks passed, and any deviations or non-conformances. This creates a complete, unalterable, and easily searchable record for every single unit or lot produced, which is ready for audit at any time.
Absolutely. UDI management is a core strength of our platform. ArionERP can generate, assign, and manage UDIs at various packaging levels. We integrate with labeling software to print UDI-compliant barcodes, and we can help automate the submission of your device data to global regulatory databases like the FDA's GUDID. The system tracks the UDI throughout the entire lifecycle, from production to inventory and sales, ensuring complete traceability.
Our implementation follows a risk-based approach aligned with GAMP 5 principles. It begins with a thorough discovery phase to define your User Requirement Specifications (URS). We then configure the system and help you execute a formal validation plan, including IQ, OQ, and PQ testing. Our team consists of industry veterans who understand the unique documentation and testing rigor required in the medical device space. We focus on a phased rollout to minimize disruption and ensure a compliant, successful go-live.
ArionERP is built on a modern architecture with robust APIs, allowing for seamless integration with other critical business systems. We have pre-built connectors for many popular PLM systems to synchronize BOMs and engineering changes. While our ERP has a strong, integrated QMS module, we can also integrate with your existing, standalone QMS software to ensure data flows smoothly for things like CAPAs, complaints, and training records, preventing duplicate data entry and ensuring a single source of truth.
Ready to Achieve Total Control and Compliance?
Stop struggling with generic software and manual processes. Schedule a personalized demo with one of our medical device industry experts to see how ArionERP can transform your operations, streamline compliance, and accelerate your path to market.
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