End-to-End Manufacturing Capabilities
From initial concept to final delivery, we provide comprehensive solutions for complex medical, electromechanical, and mechanical devices, ensuring precision, quality, and regulatory compliance at every step.
Our Delivery Process
Our streamlined, quality-focused approach takes your device from concept to market with precision and efficiency. We also guide founders through business planning, company formation, go-to-market, and early revenue.
Design Support
Expert engineering consultation and optimization
Prototyping
Rapid prototyping and iterative testing
Manufacturing
Precision production at scale
Quality Control
Rigorous testing and validation
Logistics
Global delivery and supply chain
Design Support
Expert engineering consultation and optimization
Prototyping
Rapid prototyping and iterative testing
Manufacturing
Precision production at scale
Quality Control
Rigorous testing and validation
Logistics
Global delivery and supply chain
Made in the USA. Priced for the Global Market.
Our expert team provides end-to-end precision manufacturing for complex devices. We specialize in in-house plastic tool design and molding from our state-of-the-art U.S. facility.
Design & Engineering
- Product development consultation
- CAD design and optimization
- Design for manufacturability (DFM)
- Material selection guidance
Prototyping & Testing
- Rapid prototype development
- Functional testing protocols
- EMI/RFI and acoustic testing chambers
- Iterative design refinement
Precision Manufacturing
- Micro-level machining and molding
- Clean room assembly
- Custom plastic tool design and molding
- Custom tooling and fixtures
Quality Assurance
- ISO 13485 compliance
- Statistical process control
- Comprehensive documentation
- Batch record management
Regulatory Support
- FDA submission support
- CE marking assistance
- Design history file (DHF)
- Risk management (ISO 14971)
Supply Chain & Logistics
- Global supplier network
- Inventory management
- Just-in-time delivery
- Cold chain logistics
Technical Specifications & Standards
Our manufacturing capabilities meet the highest industry standards, with state-of-the-art equipment and rigorous quality controls.
Manufacturing Standards
Production Capabilities
Ready to Transform Your Device Vision?
Partner with Elite Custom Solutions for comprehensive manufacturing excellence. From concept to delivery, we are your trusted partner in complex device innovation, helping entrepreneurs take their ideas to market. From business plans and company formation to go-to-market and first revenue.