ERP for Medical Device Manufacturers: Your Compliance Command Center
Navigate FDA 21 CFR Part 11, ISO 13485, and UDI mandates with confidence.
ArionERP delivers end-to-end traceability and automated quality management in a single,
audit-ready platform.
Trusted by Innovative Manufacturers & Global Leaders
Stop Chasing Compliance. Start Commanding It.
In medical device manufacturing, your ERP isn't just a business tool—it's your first line of defense. Generic systems create dangerous gaps in traceability and quality control, exposing you to audit failures, recalls, and significant financial risk. ArionERP is purpose-built to close those gaps. We provide a unified, validated environment where every material, process, and record is meticulously tracked, from raw material receipt to final device shipment. Move beyond spreadsheets and disconnected systems to a single source of truth that transforms your regulatory burden into a powerful operational advantage.
Why ArionERP for Medical Device Manufacturing?
Audit-Ready Compliance
Our system is pre-configured to meet FDA 21 CFR Part 11, ISO 13485, and EU MDR/IVDR requirements, with built-in electronic signatures, validation scripts, and comprehensive audit trails.
Granular Traceability
Achieve complete, bi-directional traceability with full lot and serial number tracking. Instantly trace any component from supplier to patient, simplifying mock recalls and investigations.
Integrated Quality Management (QMS)
Manage CAPAs, non-conformances, complaints, and document control directly within your ERP. Eliminate data silos between quality and operations for faster, more informed decisions.
Automated Device History Records (eDHR)
Dynamically generate comprehensive eDHRs as products move through production. Ensure every step is documented, reviewed, and approved digitally, eliminating manual errors.
Streamlined Production Control
Optimize shop floor operations with detailed work instructions, resource scheduling, and real-time data capture. Manage complex multi-level BOMs and routings with precision.
Rigorous Inventory Management
Enforce FEFO/FIFO, manage expiration dates, and control quarantine/released inventory statuses. Maintain an accurate, compliant, and optimized supply of materials and finished goods.
Robust Supplier Controls
Maintain an Approved Supplier List (ASL), track supplier performance, and manage incoming inspections and certifications to ensure the quality of your raw materials.
AI-Powered Predictive Quality
Leverage AI and machine learning to analyze production data, identify potential quality deviations before they occur, and optimize processes for higher yields and fewer non-conformances.
Expert Implementation & Validation
Our team doesn't just install software; we partner with you. We provide expert guidance on process mapping, data migration, and system validation (IQ/OQ/PQ) to ensure a successful, compliant launch.
A Purpose-Built ERP Solution for the Entire Device Lifecycle
ArionERP provides a comprehensive suite of modules designed to manage every critical aspect of your medical device operations, ensuring compliance and efficiency from R&D to post-market surveillance.
Compliance, Quality & Regulatory Management
Embed quality into every process. Our integrated QMS module is the backbone of your compliance strategy, providing the tools to proactively manage quality and streamline audits.
- FDA 21 CFR Part 11 & GxP Compliance: Enforce system access controls, electronic signatures, and immutable audit trails for all critical data changes.
- ISO 13485 Quality Management: Manage your entire QMS framework, from document control to management reviews, within a single system.
- CAPA & Non-Conformance Automation: Initiate, investigate, and resolve quality issues with automated workflows, ensuring timely closure and effectiveness checks.
End-to-End Traceability & Device History
Gain unparalleled visibility into your product's journey. ArionERP creates an unbroken chain of data, linking every component, process, and operator to a specific device unit or lot.
- Lot & Serial Number Tracking: Capture and track unique identifiers from receiving through production to final shipment, providing granular, bi-directional traceability.
- Electronic Device History Record (eDHR): Automatically compile all production records, quality checks, materials used, and operator sign-offs into a complete, accurate eDHR for every batch.
- Unique Device Identification (UDI) Management: Generate, assign, and manage UDI data, ensuring compliance with global regulatory databases and labeling requirements.
Manufacturing & Inventory Control
Take command of your shop floor and warehouse with tools designed for the precision and control required in medical device manufacturing.
- Production & Shop Floor Control: Manage multi-level BOMs, complex routings, and work orders with integrated quality checkpoints and data collection.
- Inventory Management with Strict Controls: Enforce FEFO/FIFO picking, manage expiration dates, and segregate inventory by status (quarantine, released, rejected) across multiple locations.
- Complaint Handling & Post-Market Surveillance: Log, track, and investigate customer complaints, linking them to specific device records to identify trends and trigger CAPAs.
Supply Chain & Distribution
Ensure the integrity of your supply chain and the accuracy of your distribution network with fully integrated procurement and sales order management.
- Supplier & Materials Management: Maintain an Approved Supplier List (ASL), track supplier performance, and manage incoming material inspections and certifications.
- Sales Order & Distribution Management: Process orders with full visibility of compliant inventory, manage shipments with tracked lots/serials, and generate necessary documentation.
- Financials & Cost Accounting: Gain a true understanding of product costs by tracking materials, labor, and overhead for each production run, ensuring accurate financial reporting.
Success Stories: From Compliance Chaos to Controlled Operations
Achieving Flawless Traceability for Class III Implants
OrthopedicsClient Overview: A mid-sized manufacturer of spinal fusion cages and orthopedic implants, struggling with a paper-based DHR system and disconnected quality processes. They faced constant audit anxiety and inefficient recall simulations that took days to complete.
"ArionERP didn't just give us software; they gave us peace of mind. Our last FDA audit was the smoothest we've ever had. When the auditor asked for the full history of a specific implant lot, we produced the complete eDHR in under a minute. That's a game-changer."
Key Challenges
- Manual, error-prone paper Device History Records.
- Lack of real-time visibility into shop floor operations.
- Inability to quickly trace components for mock recalls.
- Siloed QMS leading to delayed CAPA resolution.
Our Solution
- Implemented ArionERP with eDHR and integrated QMS modules.
- Deployed shop floor data collection terminals for real-time tracking.
- Configured bi-directional lot traceability from raw titanium to sterile finished good.
- Automated CAPA workflows, linking them directly to production records.
Scaling Production for a High-Growth Surgical Tool Startup
Surgical InstrumentsClient Overview: A venture-backed startup producing innovative laparoscopic instruments. Their rapid growth outpaced their QuickBooks and spreadsheet-based system, leading to inventory inaccuracies, production bottlenecks, and an inability to meet ISO 13485 documentation requirements for their upcoming certification audit.
"We were growing so fast that our processes were breaking. ArionERP provided the scalable foundation we needed to get organized, pass our ISO audit on the first try, and confidently ramp up production. It was the single best investment we made in our infrastructure."
Key Challenges
- No formal inventory control system (FEFO/FIFO).
- Inability to generate compliant DHRs for production lots.
- Lack of a centralized document control system for SOPs.
- Difficulty forecasting material requirements for production.
Our Solution
- Deployed ArionERP's cloud-based solution for rapid implementation.
- Established a full inventory management system with lot control and status segregation.
- Implemented the core manufacturing and quality modules.
- Provided training on best practices for compliant documentation and record-keeping.
Mastering Complex BOMs and Reagent Lot Control
In-Vitro DiagnosticsClient Overview: An established IVD company producing diagnostic test kits. They struggled with managing complex, multi-level BOMs with specific reagent expiration dates and formulation requirements. Their existing system couldn't enforce the strict lot-to-lot consistency and documentation needed for their products.
"The level of control ArionERP gives us over our formulations and inventory is incredible. We can now enforce expiration date rules automatically in production, which has virtually eliminated the risk of using expired reagents. Our batch consistency has never been better."
Key Challenges
- Managing BOMs with dozens of components and sub-assemblies.
- Preventing the use of expired or quarantined reagents.
- Ensuring batch-to-batch consistency in formulations.
- Documenting every step of the kitting and assembly process.
Our Solution
- Implemented advanced manufacturing with formula/recipe management.
- Configured strict inventory controls based on expiration and quality status.
- Automated the eDHR to capture precise measurements and component lots for each batch.
- Integrated with lab equipment for direct data capture, reducing manual entry.
Your Path to Validated, Compliant Operations
We follow a proven, structured methodology to ensure your ERP implementation is not only successful but also fully compliant and tailored to your unique processes.
Discovery & Process Mapping
We dive deep into your current workflows, quality procedures, and regulatory requirements to design a solution that fits your business perfectly.
Configuration & Customization
Our experts configure ArionERP to your specifications, building the custom fields, workflows, and reports needed to manage your operations.
Data Migration & Integration
We securely migrate your critical data—BOMs, inventory, supplier lists—into ArionERP and integrate with other essential systems like CAD or LIMS.
Validation & Training (IQ/OQ/PQ)
We support your validation efforts with comprehensive documentation and testing protocols, and provide thorough training to ensure your team is confident and competent.
Go-Live & Continuous Support
We provide hands-on support during your go-live transition and offer ongoing assistance to help you continuously improve and optimize your use of the system.
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What Our Clients Say
"The traceability is airtight. We can pull a full device history in seconds, which used to be a full-day fire drill. ArionERP has fundamentally improved our quality posture."
"As a startup, we needed a system that could grow with us and get us through our initial audits. ArionERP delivered a compliant, scalable platform without the enterprise price tag."
"Their implementation team understood our industry's nuances. They weren't just IT people; they were partners who helped us align our processes with best practices for compliance."
Frequently Asked Questions
Yes, absolutely. ArionERP has a built-in module specifically for 21 CFR Part 11 compliance. It enforces unique user logins, role-based security, and requires electronic signatures (with name, date, time, and meaning) for critical actions like batch release, document approval, and changes to master records. All actions are captured in a secure, computer-generated audit trail that cannot be altered.
ArionERP provides a framework to manage many core requirements of ISO 13485. This includes integrated modules for Document Control (SOPs, work instructions), CAPA management, Complaint Handling, Supplier Management (ASL), Employee Training Records, and, most importantly, the creation of Device History Records (DHR). By centralizing these processes, you can more easily demonstrate control and consistency to auditors.
Yes. While we provide a validated core platform, we understand that final validation is the responsibility of the medical device manufacturer. To support this, we provide comprehensive validation documentation packets, including Installation Qualification (IQ) and Operational Qualification (OQ) test scripts. Our implementation team will work closely with your quality department to assist with your Performance Qualification (PQ) and final validation process.
Traceability is a core function. Every raw material receipt is assigned a unique internal lot number. This number is tracked as the material is consumed in production. The finished good is then assigned its own lot or serial number, which maintains a link to all component lots used. This creates a complete, bi-directional tree, allowing you to trace from a finished device back to all its raw materials, or from a raw material lot forward to all the finished devices it was used in.
Timelines vary based on complexity, but a typical implementation for a small to mid-sized medical device manufacturer ranges from 4 to 9 months. This includes process mapping, configuration, data migration, validation support, and training. We focus on a phased approach, often starting with core inventory, manufacturing, and quality modules to deliver value quickly before expanding to other areas.
Ready to Transform Your Compliance and Operations?
Schedule a personalized demo with one of our medical device industry experts. We'll show you exactly how ArionERP can solve your specific challenges with traceability, quality management, and regulatory reporting.
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