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Development of Scalable SaaS Manufacturing Execution System for Medical Industry Compliance

faciletechnolab.com

Manufacturing

Medical

Information technology

Challenges in Medical Manufacturing Compliance

Small-to-midsize medical manufacturers in Australia face mandatory government compliance requirements for tracking and auditing production processes but lack access to affordable, customizable manufacturing execution systems. Existing solutions fail to address multitenancy, data isolation, workflow configurability, and user-friendly interfaces for diverse manufacturing use cases.

About the Client

A technology startup specializing in SaaS solutions for regulated industries, seeking to expand its footprint in the medical manufacturing sector through scalable compliance-focused software.

Objectives for SaaS MES Development

Build a scalable SaaS MVP with multitenant architecture for medical manufacturing compliance
Ensure configurable workflows and data isolation for multiple clients
Implement intuitive interfaces for shop floor operations and quality control
Achieve rapid onboarding of 5+ medical manufacturers within 10 months
Secure government recognition and funding for scalable growth

Core System Functionalities

Device History Record (DHR) for audit-compliant manufacturing tracking
Configurable quality control checkpoints with test result documentation
Inventory management with supply tracking and quality checks
Real-time shop floor monitoring with SOP integration
Customizable dashboards for production analytics and reporting
Tenant-specific subdomain routing and configuration management

Technology Stack Requirements

Angular with Bootstrap for front-end UI

ASP.NET Core 2.1 and Entity Framework for backend

PostgreSQL with single-host/multi-tenant database architecture

AWS services (EC2, Route 53, ALB, ASG) for cloud hosting

REST API/Swagger for service integration

External System Integrations

Third-party analytics platforms
Government compliance verification systems
Social media sharing components
Payment gateways for subscription management

System Performance Criteria

High-availability cloud architecture with autoscaling
Role-based access control and data encryption
Sub-200ms response times for core operations
Modular design for rapid client-specific customizations
Compliance with medical device manufacturing data standards

Expected Impact on Medical Manufacturing Industry

The solution will enable small medical manufacturers to meet regulatory requirements at 60% lower cost than traditional MES systems. Successful implementation will position the client as a government-recognized compliance solutions leader, accelerate onboarding of 5+ manufacturers within 10 months, and create a scalable foundation for expanding into adjacent regulated industries.