Medical Device ERP: Master Compliance & Accelerate Production
Finally, an ERP built to navigate the complexities of FDA 21 CFR Part 11, ISO 13485, and UDI regulations.
Stop wrestling with spreadsheets and start shipping compliant products, faster.
Trusted by Global Leaders in Manufacturing, Healthcare, and Technology
Why ArionERP for Medical Device Manufacturing?
We built our ERP to solve the specific, high-stakes challenges of your industry. We don't just offer software; we deliver certainty in a world of complex regulations.
Audit-Ready Compliance
Our system is architected for FDA 21 CFR Part 11 and ISO 13485. Generate documentation, maintain audit trails, and manage electronic signatures with a system that's always ready for inspection.
Unbreakable Traceability
Gain end-to-end visibility with granular lot and serial number tracking. Instantly trace every component from supplier receipt to finished device shipment, minimizing recall scope and risk.
Proactive Quality Management
Move beyond reactive fixes. Our integrated CAPA, non-conformance (NC), and supplier corrective action (SCAR) modules turn quality management into a data-driven, preventative process.
Automated DHR & DMR
Eliminate paper-based Device History Records and Device Master Records. Our system automatically compiles all production, quality, and material data into a compliant, electronic record (eDHR/eDMR).
Expert-Led Implementation
Our team understands medical device validation (IQ, OQ, PQ). We partner with you to ensure your ERP implementation is not just technically sound, but fully validated and compliant from day one.
Data-Driven Operations
Make informed decisions with real-time dashboards for production yield, quality trends, and supply chain performance. Stop guessing and start optimizing every facet of your operation.
Integrated Inventory Control
Manage raw materials, WIP, and finished goods with precision. Handle expiry dates, quarantine statuses, and supplier-managed inventory seamlessly within a single, unified system.
Scalable Cloud Platform
Grow your business without outgrowing your ERP. Our secure, scalable cloud infrastructure ensures high availability and performance, whether you're a startup or a multi-site enterprise.
Dedicated Lifecycle Support
We are your long-term partner. From initial implementation and training to ongoing support and system updates, our team is committed to your success in a constantly evolving regulatory landscape.
A Unified Platform for Medical Device Excellence
ArionERP provides a comprehensive suite of modules, purpose-built to manage the entire product lifecycle from R&D to post-market surveillance, all within a single, compliant framework.
Quality & Compliance Management
Embed quality into every process. Our QMS module is the compliant core of your operations, ensuring you meet and exceed regulatory standards.
- CAPA & Non-Conformance (NC) Management: Initiate, investigate, and resolve quality issues with a closed-loop corrective and preventive action process.
- Document Control & e-Signatures: Manage SOPs, work instructions, and specifications with version control, approval workflows, and FDA 21 CFR Part 11 compliant electronic signatures.
- Audit Management & Reporting: Schedule and conduct internal and external audits, track findings, and generate comprehensive reports to demonstrate compliance.
Manufacturing & Production Control
Digitize your shop floor and gain complete control over the manufacturing process, ensuring consistency, quality, and full traceability.
- Device History Record (DHR) Automation: Automatically compile a complete, error-free eDHR for every device or lot, capturing all materials, labor, quality checks, and process parameters.
- Device Master Record (DMR) Management: Maintain a centralized, version-controlled repository for all specifications, drawings, and manufacturing procedures that define your product.
- Production Order & Shop Floor Control: Manage work orders, track production progress in real-time, and enforce procedural steps to ensure products are built to specification every time.
Inventory & Supply Chain
Achieve precision control over your entire supply chain, from raw material sourcing to finished device distribution, all while maintaining strict traceability.
- Lot & Serial Number Traceability: Track every component and finished good with unique identifiers, enabling instant forward and backward traceability for investigations and recalls.
- UDI & Labeling Management: Generate, manage, and print Unique Device Identification (UDI) compliant labels directly from the system, ensuring regulatory adherence.
- Supplier Controls & SCARs: Manage approved supplier lists (ASL), track supplier performance, and issue Supplier Corrective Action Requests (SCARs) to resolve component quality issues.
Core Business Operations
Integrate every department onto a single source of truth, breaking down data silos and driving enterprise-wide efficiency.
- Finance & Accounting: Manage financials with a clear view of product costing, R&D expenses, and overall profitability, all integrated with your operations.
- Sales & CRM: Manage customer relationships, track complaints for post-market surveillance, and handle sales orders for medical devices, including kits and loaner sets.
- R&D and Project Management: Track new product development projects, manage design controls, and link R&D activities directly to the DMR and production processes.
Real-World Results for Medical Device Innovators
See how we've helped companies like yours overcome their biggest compliance and operational hurdles to achieve sustainable growth.
Client Overview
A venture-backed startup developing a novel Class II diagnostic device. They had a brilliant product but lacked the internal systems to manage design controls and prepare for their first FDA 510(k) submission, relying on a chaotic mix of spreadsheets and cloud storage.
"ArionERP gave us the structure and control we needed to look and act like a mature company. The auditors were impressed with our eDHR system, which was a huge factor in our successful submission."
- Michael Brooks, Head of Quality & Regulatory, CardioTech Solutions
The Challenge: From Innovation to Compliant Production
The client needed to establish a compliant Quality Management System from scratch and prove to regulators that their manufacturing process was under control, repeatable, and fully documented.
- Establishing compliant Design History Files (DHF).
- Lack of a formal document control and change order process.
- Inability to create a Device Master Record (DMR) for production.
- No system for tracking initial production lots and quality data.
Our Solution: A "QMS-in-a-Box" ERP Implementation
We deployed our QuickStart package, focusing on the core modules needed for regulatory submission and initial manufacturing.
- Implemented the Document Control module for all SOPs and design files.
- Used the Bill of Materials and Routing modules to build the first eDMR.
- Configured the Production module to automatically generate eDHRs for pilot builds.
- Trained the team on basic CAPA and Non-conformance workflows.
Client Overview
A well-established, 150-employee manufacturer of orthopedic implants. Their business was growing, but their paper-based Device History Record (DHR) system was causing significant production delays, data entry errors, and consuming massive amounts of storage space.
"The switch to eDHRs was transformative. We've reclaimed an entire room of filing cabinets and, more importantly, our review and release times have been cut in half. We can find any record from any lot in seconds, not hours."
- Olivia Bishop, VP of Operations, OrthoInnovate Inc.
The Challenge: The Paperwork Bottleneck
Every production batch generated a thick binder of paper that had to be manually filled out, reviewed, and physically archived. This process was slow, prone to errors, and made trend analysis nearly impossible.
- Delayed product release cycles due to lengthy DHR review.
- High risk of incomplete or inaccurate data entry on the shop floor.
- Inability to quickly analyze historical production and quality data.
- Significant overhead costs for printing, storing, and retrieving paper records.
Our Solution: Phased Digital Transformation
We implemented ArionERP with a focus on digitizing the shop floor and automating the DHR process, integrating directly with their existing manufacturing equipment.
- Deployed shop floor terminals for real-time data entry into the eDHR.
- Automated the capture of quality inspection data at critical process steps.
- Created workflows for electronic review and approval of completed eDHRs.
- Built real-time dashboards to monitor yield, scrap, and cycle times.
Client Overview
A multi-national producer of disposable medical supplies that had received an FDA warning letter related to inadequate CAPA processes and poor supplier management. They needed to rapidly implement a robust, compliant system to avoid further regulatory action.
"ArionERP was central to our remediation plan. It provided the traceability and process control we needed to demonstrate to the FDA that our issues were resolved. The integrated CAPA and SCAR modules are now the backbone of our quality system."
- Carter Fleming, Director of Global Quality, MedSupply Enterprise
The Challenge: Remediating Critical Compliance Gaps
The client's existing systems were disconnected, making it impossible to link customer complaints to specific production lots or supplier components. Their CAPA process was manual, poorly tracked, and lacked effectiveness checks.
- Inability to perform timely and effective root cause analysis.
- Lack of a closed-loop system for CAPA and SCAR tracking.
- Poor visibility into supplier quality performance.
- Risk of production shutdown or product seizures.
Our Solution: An Integrated Quality & Supply Chain Overhaul
We executed an accelerated implementation of the Quality, Inventory, and Purchasing modules to create a single source of truth and enforce compliant workflows.
- Implemented the full CAPA module with enforced workflows for investigation, action, and effectiveness verification.
- Activated the SCAR module to formally track and resolve supplier quality issues.
- Used the lot traceability features to link every finished good back to its raw material lots.
- Developed supplier scorecards based on incoming inspection and on-time delivery data.
Built on a Foundation of Modern, Secure Technology
Our platform integrates seamlessly with your existing infrastructure and is built using industry-standard technologies to ensure reliability, security, and scalability.
What Our Clients Say
We're proud to be a trusted partner in our clients' success. Hear directly from the leaders who rely on ArionERP every day.
"The level of detail in the lot traceability is phenomenal. During a mock recall, we were able to identify every affected unit in under 10 minutes. That level of speed and accuracy is simply impossible with a manual system."
Ava Harrington
QA Manager, Surgical Solutions LLC
"ArionERP's integrated document control module was a game-changer for our 21 CFR Part 11 compliance. The electronic signature workflow saved us countless hours and eliminated our paper-based approval routing."
Benedict Hale
IT Director, Diagnostics Inc.
"As a CFO, I finally have a real-time, accurate view of our cost of goods sold. The system's ability to tie material and labor costs directly to each production run has been invaluable for our financial planning and pricing strategies."
Claire Baxter
Chief Financial Officer, Precision Implants
"The implementation team's knowledge of medical device validation was top-notch. They didn't just install software; they helped us develop and document our IQ/OQ/PQ protocols, which was a huge weight off our shoulders."
Dante Cole
COO, Vital Monitoring Systems
"Managing our approved supplier list and tracking component certifications used to be a nightmare of spreadsheets. Now, it's all integrated. We can't even receive a component if the supplier isn't approved or a certification has expired."
Eliana Pratt
Supply Chain Director, Endoscopic Devices Co.
"The ability to link customer complaints directly to a DHR and initiate a CAPA from a single screen has streamlined our entire post-market surveillance process. It connects the dots in a way our old systems never could."
Felix Prince
Head of Post-Market Quality, NeuroStim Devices
Frequently Asked Questions
Have questions? We have answers. Here are some of the most common inquiries about ArionERP for Medical Devices.
ArionERP is "validation-ready." We provide a comprehensive validation package, including IQ (Installation Qualification) and OQ (Operational Qualification) documentation. We then partner with you to complete the PQ (Performance Qualification) process, which is specific to your unique use of the system. Our software is designed with all the necessary features, such as audit trails, electronic signatures, and access controls, to meet the technical requirements of regulations like FDA 21 CFR Part 11 and ISO 13485.
ArionERP automates the creation of electronic DHRs (eDHRs). As a product moves through the manufacturing process, the system automatically collects all relevant data: materials used (with lot numbers), labor time, machine parameters, quality inspection results, and any deviations or non-conformances. This creates a complete, time-stamped, and unalterable record for every batch or serial number, which can be reviewed and approved electronically.
Absolutely. Our integrated Quality Management module provides a closed-loop system for managing Corrective and Preventive Actions (CAPA) and Non-conformances (NC). You can initiate an NC or CAPA from anywhere in the system (e.g., a failed inspection, a customer complaint), manage the investigation and root cause analysis, assign actions, and track them to completion, including effectiveness checks. All actions are documented in a compliant, auditable record.
Implementation timelines vary based on complexity, but a typical phased implementation for a small to mid-sized medical device company can range from 4 to 9 months. We focus on a "crawl, walk, run" approach, often starting with core financials, inventory, and quality modules to establish a compliant foundation, followed by shop floor control and advanced features. Our QuickStart package is designed for a faster, more streamlined deployment for startups and companies with less complex needs.
We offer comprehensive, ongoing support as a long-term partner. Our support plans (Silver, Gold, Platinum) provide access to our expert team for technical assistance, troubleshooting, and guidance. We also manage all system updates and maintenance for our cloud customers, ensuring you are always on the latest, most secure version of the software. We understand the critical nature of your operations and are committed to ensuring your system runs smoothly.
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 and help you get to market faster, with less risk.
Request Your Free Demo