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Medical Device ERP for Regulated Manufacturing Needs

Accelerate market readiness with full traceability and operational precision with our AI-powered medical device ERP system. Built by Folio3 Digital Health, it meets the industry-specific demands of medical device manufacturing and paves the road to compliant, scalable growth.
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Medical Device ERP: A Must-Have for Manufacturer

Medical device manufacturers are caught between the need to innovate and the pressure to comply with increasingly strict regulations. With the global market projected at 681.57 billion in 2025 and expected to reach USD 955.49 billion by 2030, balancing both has become a real challenge. Ensuring audit readiness, traceability, and quality is non-negotiable, but traditional ERPs often fall short. Most lack real-time insights, healthcare domain expertise, and the flexibility needed to drive growth without compromising compliance.
Folio3 Digital Health offers a value-driven ERP for medical device manufacturers that automates compliance workflows, enhances quality with AI analytics, and provides full supply chain traceability. Our seamless integration with EHRs, telehealth, and IoMT devices helps manufacturers innovate faster, reduce risks, and improve patient outcomes.

Core Modules of ERP for Medical Device Manufacturers

Quality Management System

  • Built-in NC and CAPA tracking in ERP for the medical device industry
  • Enforce QC checkpoints during every production phase
  • Proactive issue detection via automated notifications
QMs

Manufacturing Execution System (MES)

  • End-to-end lot tracking from raw materials to final assembly
  • Manage work orders and track lot/batch-level progress
  • Monitor real-time OEE and downtime analytics
mes

Inventory & Warehouse Management

  • Full visibility into raw materials and finished goods
  • Automate expiry date alerts for sensitive components
  • Manage stock aging, recalls, and shelf-life risks
inventory

Supply Chain Management

  • Qualify suppliers with performance and compliance metrics
  • Align stock with your demand for managing goods at an optimal level
  • Monitor traceable sourcing across vendors and product lines
supply chin management

Product Lifecycle Management (PLM)

  • Centralized control over device lifecycle from concept to retirement
  • Consolidated design updates with manufacturing systems
  • R&D and production collaboration in the medical device ERP
financial management

Financial Management

  • Foster financial control with cost transparency
  • AI-powered tracking of manufacturing costs per product or batch
  • Align financial planning with FDA and global compliance needs
financial management

Customer Relationship Management (CRM)

  • Manage relationships with hospitals, clinics, and distributors
  • Centralize sales activity, feedback, and service interactions
  • Monitor contract performance and pricing compliance
CRM

Sales & Distribution Management

  • Handle end-to-end sales cycle from quotes to orders and billing
  • Manage distributor and reseller workflows in medical device ERP software
  • Real-time updates for order status and inventory levels.
sales distribution

Analytics & Reporting

  • Cross-module analytics powered by AI insights
  • Enables cold chain integration, monitors the supplier, and provides shipment alerts
  • AI-backed audit logs and readiness reports for inspections
Analytics reporting

Medical Device ERP Capabilities for Compliance and Efficiency

ai-driven
AI-Driven Demand Forecasting
  • Our ERP software for medical device manufacturers predicts market needs with AI demand forecasting across healthcare facilities and distributors, enabling smarter production planning and inventory control.
  • Identify potential quality issues before they occur with our custom medical device surgical ERP that analyzes production data, detects anomalies, triggers alerts, reduces recalls, and ensures compliance by leveraging AI.
  • We help your company always be prepared for audits. Our medical device ERP software automatically keeps track of all your important records, so you continuously meet FDA and ISO rules and don’t get penalized during inspections.
  • Use AI-powered tools to manage your inventory better. Our ERP system automatically tracks how stock moves and how long items last, to avoid overstocking, reduce waste, and keep the right amount of supplies available across your warehouses and production lines.
  • Monitor operations with intelligent dashboards that surface the most critical metrics. They send alerts before escalation by highlighting production delays, quality outliers, and compliance risks in real time.

Delivering Value with our AI-Driven Medical Device ERP System

Faster Time to Market

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Faster Time to Market

  • Reduce cycle times across the process to accelerate product development
  • Streamline every phase across departments from design to distribution for faster execution

Operational Efficiency

  • Eliminate silos, automate manual processes and boost productivity with medical device ERP
  • Reduce rework, delays, and administrative overhead with AI-enabled workflows

Increased Visibility

Our ERP solutions enhance decision-making, resource allocation, and patient care delivery with healthcare data analytics services that leverage advanced analytics, artificial intelligence (AI) predictive insights, and automated workflows.

Increased Visibility

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Increased Visibility

  • Real-time insights into inventory, production, compliance, and financials
  • Improve planning and responsiveness with full data transparency

Resource Optimization

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Resource Optimization

  • Analyzes usage trends to allocate resources efficiently and minimize waste
  • Keep operations lean by reducing downtime and making better use of every asset

Data-Driven Decision Making

  • Smarter business decisions with AI-enhanced reporting and predictive analytics
  • Initiatives in a medical device ERP system based on operational and financial data

Regulatory Compliance

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Regulatory Compliance

  • Built-in compliance tracking, digital signatures, and automated documentation
  • Simplify adherence to FDA, ISO, and global regulatory frameworks
Discover Our Benefits

End-to-End Services for ERP for Medical Device Manufacturers

ERP Implementation & Customization

We implement medical device ERP systems with custom modules for QMS, traceability, and compliance built from day one for rapid configuration.

Regulatory Compliance

Our ERP systems ensure and adhere to industry-specific regulations like FDA, ISO 13485, CE, and CFR Part 11 with full validation support.

ERP Integration Services

Enable real-time data flows by connecting your ERP for medical device manufacturers with PLM, CRM, QMS, and shop floor systems.

Data Migration

We ensure safe data migration from your legacy systems while preserving audit trails and compliance records.

Post-Implementation Support

Our team maintains ERP reliability with 24/7 ERP support, system health checks, and performance tuning.

User Training

We provide training to your teams to boost adoption with role-based onboarding and change management programs.

Contact Our Support Team

Medical Device ERP Integration with Your Healthcare System

EHR/EMR Systems
IoMT & Device Data
Core Business System Integration
Business Intelligence & Analytics

EHR/EMR Systems

Synchronize patient data with your ERP and automate the exchange of records for improved care coordination.

IoMT & Device Data

Integrate data streams from medical devices and IoMT with medical device ERP for better outcomes.

Core Business System Integration

Integrate across product lifecycle, quality management, customer relationships, and HR operations.

Business Intelligence & Analytics

Enhance decision-making with AI-integrated healthcare BI solutions and analytics tools for real-time insights.

What Sets Folio3 Apart in Medical Device ERP Software

Healthcare & MedTech Expertise
  • With over 20+ years of experience, Folio3 Digital Health specializes in serving healthcare providers and medical device manufacturers with custom AI-powered healthcare and medical device software development.
  • Our team brings their experience in customizing healthcare ERP solutions with platforms like NetSuite and Microsoft Dynamics 365, configured specifically for the needs of FDA-regulated manufacturing.
  • We strictly adhere to protocols to ensure that our custom ERP for the medical device industry is FDA 21 CFR Part 11, ISO 13485, CE, and HIPAA compliant.
  • Whether you're integrating QMS, PLM, CRM, HRMS, or building device-specific apps, we offer custom integration services that connect the medical device ERP with your entire system.

Client Testimonials

Kudos to your team for outstanding work in the discovery phase! Your team understood our business and workflows by asking the right questions and extracting the most useful information. Your team's ownership and results-oriented approach are commendable.

I appreciate your remarkable work during the  recent Laboratory service phase. Your determination, analytical thinking, and continuous efforts were crucial in overcoming challenges and achieving success. I appreciate your help as we collaborate to create fantastic items.

Folio3 Digital Health Testimonial

Working with the folio3 team has been a great experience. Your dedication, creativity, and adaptability in overcoming challenges for the Moodology app project are truly commendable.

Folio3 Digital Health Testimonial
Folio3 Digital Health Testimonial

Team Folio3 brought my dream app to reality, they explained every step to our non technical team professionally. wireframe and design processes were outstanding  & they built stunning and perfectly integrated application. I think both patients and clinic will be significantly benefited.

Folio3 Digital Health Testimonial

5-Step Process for Medical Device ERP Implementation

01.

Discovery and Planning

Starting from comprehensive assessments of your healthcare facility’s unique needs and challenges, we define goals and objectives to address in the ERP for the medical device system.

02.

Tailored System Design

After gathering the necessary information, we tailor ERP modules according to your needs with industry-specific healthcare UX/UI design and ensure they integrate with your existing workflows, providing seamless functionality.

03.

Implementation & Integration

Our team ensures a smooth, on-time implementation, integrating with your digital health ecosystem to support efficient, connected operations.

04.

Training & Change Management

Through targeted training and robust change management, we ensure your team adapts to the new system and is prepared to use the latest medical device ERP system effectively.

05.

Ongoing Support & Optimization

After go-live, we provide ongoing system monitoring, support, and regular compliance updates to ensure your ERP system remains current and effective.

Frequently Asked Questions

What is the main benefit of implementing an ERP for medical device manufacturers?
Medical device ERP centralizes operations by integrating various functions, which means streamlined workflows, faster product lifecycle management, reduced risk of errors, and improved compliance tracking, resulting in greater operational agility.
Our medical device manufacturing ERP software supports stringent regulatory needs, including FDA 21 CFR Part 820, ISO 13485, CE, and MDR, ensuring compliance is built into every step of your operations, minimizing the risk of non-conformance, and speeding up validation cycles.
Our ERP integrates seamlessly with Quality Management Systems (QMS), Manufacturing Execution Systems (MES), and Product Lifecycle Management (PLM) platforms. Ensuring end-to-end visibility, real-time data synchronization, and a unified digital thread.
Implementation cost for ERP software for medical devices varies based on the organization’s size, supply chain complexity, and regulatory requirements. Folio3 Digital Health offers a custom ERP, which generally costs between US$ 25,000 and US$ 500,000,
Implementation typically takes between 3 to 12 months, depending on the scale and scope of integration (e.g., with QMS, PLM, or legacy systems). We follow a phased approach to minimize disruption to production or regulatory timelines.
AI enhances critical ERP functions by enabling predictive maintenance, accurate demand forecasting, and automated Corrective and Preventive Actions (CAPA). It proactively identifies quality trends, prevents non-conformances, and ensures regulatory compliance while driving operational efficiency.

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