ERP for Medical Device Manufacturers: Compliance, Traceability, and Growth. All in One.
Navigate FDA regulations, manage complex supply chains, and ensure total quality control with an AI-enhanced ERP built for the unique demands of the medical device industry.
ArionERP delivers the digital backbone you need to innovate safely and scale efficiently.
Your Devices Save Lives. Your ERP Should Save You.
In the medical device industry, there is no room for error. You operate under intense scrutiny, where product quality, regulatory compliance, and complete traceability are not just business goals—they are absolute mandates. Juggling FDA 21 CFR Part 11, ISO 13485, Unique Device Identification (UDI), and rigorous quality control while trying to innovate and grow is a monumental task. Legacy systems and disconnected spreadsheets create risks, inefficiencies, and compliance gaps that can have severe consequences. ArionERP replaces this complexity with a single, unified, AI-enhanced platform designed to master the specific challenges of your industry, giving you the confidence to focus on what matters most: delivering life-changing products.
Why ArionERP is the Right Choice for Medical Device Manufacturers
End-to-End Traceability
Achieve complete, forward-and-backward lot and serial traceability from raw materials to finished goods. Instantly access full device history records (DHR) and respond to audits with confidence.
Built-in Compliance
Our system is designed with FDA 21 CFR Part 11 and ISO 13485 standards in mind, featuring electronic signatures, audit trails, and robust security protocols to simplify your compliance burden.
Integrated QMS
Unify your Quality Management System within your ERP. Manage CAPAs, non-conformances, change orders, and employee training records in one place, ensuring quality is embedded in every process.
Streamlined UDI Management
Automate the generation, labeling, and submission of Unique Device Identification data to the FDA's GUDID. Eliminate manual errors and ensure every device is correctly tracked.
Robust Inventory Control
Manage shelf life, expiration dates, and FEFO (First-Expired, First-Out) picking with precision. Avoid waste and ensure product efficacy with intelligent, multi-location inventory management.
Digital Device History
Eliminate paper-based Device History Records (DHRs). Our system automatically compiles all production, quality, and material data into a secure, easily accessible electronic DHR for every unit.
AI-Powered Insights
Leverage artificial intelligence for predictive maintenance on manufacturing equipment, demand forecasting based on market trends, and anomaly detection in your quality control data to prevent issues before they occur.
Validated System Support
We understand the importance of system validation. We provide comprehensive documentation and support services (IQ, OQ, PQ) to assist you in your software validation process, saving you time and resources.
Scalable Platform
Whether you're a startup launching your first device or an established enterprise expanding your product line, ArionERP scales with you, supporting multi-plant operations, global supply chains, and evolving regulatory landscapes.
A Comprehensive ERP Solution for the Entire Device Lifecycle
ArionERP provides a complete suite of integrated, AI-enhanced modules designed to manage every facet of your medical device manufacturing operations, from initial design to post-market surveillance.
Real-World Success in Medical Device Manufacturing
Our Proven Implementation Methodology
1. Discovery & Scoping
We begin with a deep dive into your specific processes, compliance requirements, and business goals. Our experts work with your team to map workflows and define the project scope, ensuring a perfect fit.
2. Configuration & Customization
ArionERP is configured to your unique needs. We set up modules, user roles, and workflows, and perform any necessary customizations to handle your specific device types and operational nuances.
3. Data Migration & Integration
We securely migrate your data from legacy systems into ArionERP. Our team also handles integration with other critical systems like CAD, PLM, or laboratory information management systems (LIMS).
4. Validation & Testing
We assist your team with the software validation process. We provide documentation and support for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to ensure the system operates as intended.
5. Training & Go-Live
Comprehensive training is provided to ensure your team is confident and proficient with the new system. We then manage a smooth go-live process with on-site or remote support to handle any immediate needs.
6. Ongoing Support & Optimization
Our partnership doesn't end at launch. We provide continuous support, system updates, and strategic guidance to help you optimize your use of ArionERP and adapt to new challenges and opportunities.
Integrations & Technology Ecosystem
ArionERP seamlessly integrates with the tools and platforms you already use, creating a unified technology ecosystem for your entire operation.
Trusted by Innovators in Life Sciences
Deep Expertise Across Regulated Industries
While we specialize in medical devices, our expertise extends across the manufacturing spectrum, bringing cross-industry best practices to your solution.
Meet Our Team of Industry & Technology Experts
Our team combines deep ERP implementation experience with specialized knowledge of the medical device industry's regulatory and operational challenges.
Amit A., Ph.D.
Founder & COO - Expert in Enterprise Technology Solutions for regulated manufacturing environments.
Girish S.
Delivery Manager - Microsoft Certified Solutions Architect specializing in GxP compliant cloud deployments.
Prachi D.
Manager, Certified AI & Cloud Solutions Expert, focusing on predictive quality and supply chain optimization.
Vipin S.
Lead, Certified Quality Expert, specializing in automated testing and software validation for life sciences.
Flexible Engagement Models for Your Success
Full-Scale Implementation
An end-to-end partnership where we manage the entire ERP implementation lifecycle, from discovery and configuration to go-live and ongoing support. Ideal for companies seeking a comprehensive, turnkey solution.
- Dedicated Project Manager and Team
- Complete Lifecycle Management
- Validation Support and Training Included
Team Augmentation
Supplement your internal IT or project team with our specialized ERP consultants, developers, and validation experts. We integrate seamlessly with your existing team to provide targeted expertise where you need it most.
- Access to Specialized Skillsets
- Flexible, On-Demand Resourcing
- Knowledge Transfer to Your Team
Recognized for Excellence and Quality
Our commitment to quality, security, and client success is validated by industry-leading certifications and awards.
Frequently Asked Questions
Ready to Transform Your Medical Device Manufacturing?
Let's discuss how ArionERP can help you streamline operations, ensure compliance, and accelerate growth. Schedule a free, no-obligation consultation with one of our industry experts today.
Schedule Your Free Consultation