ERP for Medical Equipment Industry
End-to-End ERP for Medical Devices, Diagnostic Machines & Healthcare Equipment Manufacturers
Introduction
Medical equipment manufacturers manage strict regulatory requirements, precision engineering, component traceability, device calibration, and post-sales service.
AIS Business Corp's Medical Equipment ERP integrates all processes from R&D → Design → BOM → Production → Testing → Regulatory → Warranty → Service into a single platform.
Complete Medical Equipment Manufacturing Flow
Suitable for:
Powered by SAP Technologies
SAP S/4HANA
Enterprise-grade ERP designed for large medical equipment and medical device manufacturers, assemblers, and multi-plant operations. Supports advanced finance, production planning, bill of materials (BOM), serial and lot traceability, quality management, regulatory compliance (ISO 13485, FDA, MDR), asset and calibration management, warranty and service management, supply chain control, and real-time analytics across end-to-end medical equipment operations.
SAP Business One
A complete ERP solution for small and medium medical equipment manufacturers, distributors, and service providers. Covers procurement, production or assembly tracking, serial number management, quality inspection, inventory, sales, finance, costing, warranty tracking, service and maintenance management with fast deployment and easy scalability.
Cloud ERP (Private, Public Cloud & On-Premise)
Flexible and scalable ERP deployment options tailored for medical equipment operations. Choose Private Cloud for dedicated infrastructure and enhanced data security, Public Cloud for cost-effective SaaS deployment with automatic updates, or On-Premise for full control, deeper customization, and seamless integration with QMS, calibration systems, service management platforms, IoT-enabled devices, and legacy applications.
Key Challenges in Medical Equipment Manufacturing
Strict Regulatory Compliance
ISO 13485, CE, FDA, CDSCO, and country-specific regulations require controlled documentation.
Need for Batch / Serial Traceability
Each device must be traceable from component to patient/hospital.
High-Precision BOM & Engineering
Multi-level BOM with electronics, mechanical parts, and consumables.
Mandatory Testing & Calibration
Every device must pass electrical, safety, and performance tests.
Service Management & Warranty Tracking
After-sales service is crucial for medical equipment usage.
Sensitive Production Conditions
Environmental conditions, calibration logs, and quality checks.
AIS Medical Equipment ERP - Complete End-to-End Solution
R&D, Engineering & Design Control
- Engineering BOM creation
- Revision control / versioning
- CAD integrations
- Controlled document management
- Design inputs & outputs tracking
- Engineering change order (ECO) system
Material Requirement Planning (MRP)
- Component forecasting
- Long lead-time electronic parts planning
- Supplier comparison
- Make/Buy analysis
- Auto material request generation
Procurement & Supplier Quality Management
- Supplier evaluation & approvals
- Incoming QC for sensitive components
- Vendor certificates (RoHS, REACH, CE)
- Delivery scheduling
- GRN with serial/batch scan
Production Planning & Assembly Management
- Multi-level BOM (electrical, mechanical, electronic)
- Assembly line scheduling
- Work orders for assembly / fabrication / PCB welding
- IoT-enabled machine status (optional)
- WIP tracking
- Barcode/QR for each component
Calibration & Testing Management
- Electrical testing
- Functional testing
- Safety & compliance tests
- Automated test checklist
- Calibration logs with expiry alerts
- Test certificate generation
Inventory & Component Traceability
- Batch & serial number tracking
- Component-to-device traceability
- BIN/rack storage
- FEFO for consumables
- ESD-safe storage logging
- Device history record (DHR)
Quality Control & Compliance
- Incoming QC
- In-process QC
- Final QC
- Corrective & Preventive Actions (CAPA)
- Non-conformance management (NCMR)
- Device master file (DMF)
- Regulatory documentation (ISO 13485 ready)
Sales, Dispatch & Installation
- Order processing
- Packaging & labeling as per compliance
- Delivery challan
- Installation checklist
- Customer acknowledgment
Warranty, AMC & After-Sales Service
- Warranty tracking by serial number
- AMC & service contract management
- Service ticketing
- Technician assignment
- Spare parts tracking
- On-site service mobile app
- Calibration reminders for customers
Finance & Costing
- Product costing (material + labor + overheads)
- Multi-currency billing
- GST/Tax compliance
- Project-based costing
- Customer outstanding tracking
- Profitability reports
Automation, Approvals & Alerts
Automation
AIS Medical Equipment ERP automates:
- Material issue & consumption posting
- Production & assembly confirmations
- Testing & calibration result posting
- QC approvals
- Finance & costing integration
Approvals
Approval workflows for:
- Engineering changes (ECO)
- Material indents & purchases
- Production release
- Dispatch & invoicing
Alerts
Real-time alerts for:
- Calibration expiry
- Test failures
- Excess consumption vs BOM
- Production delays
- Compliance document expiry
AI, Analytics & Intelligent ERP
Using SAP-powered analytics, the ERP delivers:
Consumption variance prediction vs BOM, Stage-wise production cost analysis, Failure trend detection in testing, Calibration due forecasting, Supplier quality performance insights, and Device-wise profitability analysis.
This enables proactive quality control and regulatory confidence.
Reports & MIS (Medical Equipment ERP)
Inventory & Stock Reports
- Stock Register
- Stock Turnover Report
Purchase & Material Control
- Indent vs Purchase vs GRN Report
- BOM vs Actual Consumption Report
- Subcontract Material Tracking Report
Production & Costing
- Stage-wise Production Output with Cost
Quality & Inspection
- Stage-wise Inspection Report
Sales
- Sales Analysis
These reports ensure full control over:
Compliance, consumption, and quality.
Advanced AIS Features
Mobile Apps
- Production updates
- QC checklists
- Technician service app
- Inventory in/out
- Delivery & installation app
- Management dashboards
Integrations Supported
- Barcode/QR
- IoT machine data
- Calibration devices
- Testing equipment
- SAP, Tally, Zoho
- Document scanners
- Digital signature
Reports & Dashboards
- Device traceability report
- Test certificate management
- Production efficiency
- Warranty & service history
- Serial number tracking
- Material consumption variance
- Sales & dispatch summary
- Regulatory audit logs
Benefits of AIS Medical Equipment ERP
Complete traceability from part to finished product
Faster design-to-manufacturing cycles
Strong compliance with ISO 13485, CE, FDA, CDSCO norms
Zero missing documents with controlled workflows
Reduced rejections with scientific QC
Accurate calibration & test documentation
Faster dispatch with serial-based scanning
Higher uptime with efficient after-sales service
Improved profitability and cost control
Why Choose AIS Business Corp
Our Implementation Process
Requirement Study (Device, QC, Compliance)
Engineering BOM Setup
QC, Calibration, and Test Workflow Configuration
Mobile App Deployment
User Training
Pilot Run & Corrections
Go-Live & Monitoring
Frequently Asked Questions (FAQ)
Does AIS ERP support ISO 13485 compliance?
Can we track serial numbers for each device?
Does it manage calibration logs?
Is service & AMC management available?
Can AIS ERP track device assembly and testing stages?
Does the system support DHR, DMR & device history?
Can we manage UDI and regulatory labeling?
Does AIS ERP handle component-level QC?
Is component, PCB, and module traceability supported?
Does it support installation & commissioning workflows?
Call to Action
Digitize your medical equipment manufacturing with AIS Business Corp's advanced ERP. Ensure safety, compliance, and complete traceability. Contact us today for a personalized demo.
Email: cm@ananthinfo.com
