Manufacturing
High-Quality Production with a Network of Global Partners.
Our Plastic Device Manufacturing leverages global partnerships to deliver high-quality, cost-effective solutions. From design to production, we ensure precision, efficiency, and scalability to meet your unique manufacturing needs.
Injection molding
Our injection molding manufacturing network ensures top-tier quality and cost efficiency. We provide custom molding solutions, material selection expertise, and streamlined production to bring your product to market faster.
Secondary operations
Our global partners provide precision secondary operations, including ultrasonic welding, heat staking, pad printing, and more to ensure your injection-molded products are production-ready with a high-quality finish.
Assemble
Our global partners provide end-to-end device assembly, including rigorous functional testing, quality inspections, and compliance checks, ensuring reliability, durability, and performance before reaching the market.
Packaging
Our global partners provide tailored packaging solutions, including custom-designed boxes, blister packs, and protective materials, ensuring your devices are securely packaged and ready for shipping or retail.
Manufacturing Service In Bookable Stages
1. Free Discovery Call
Purpose: Understand the client’s product, market, regulatory class, volume expectations, and timeline.
- Initial manufacturing intake form (volumes, device class, packaging, etc.)
- Regulatory discussion: FDA vs. CE, Class I–III device implications.
- Overview of global manufacturing options.
- Written summary of the call and proposed next steps
2. Manufacturing Feasibility & Quoting
Purpose: Assess manufacturability and provide detailed costing with vetted vendors.
- Manufacturing Feasibility Assessment.
- Cost Estimate Package (unit cost, tooling, packaging, assembly).
- Vendor Selection Matrix (comparing capabilities, certifications, geography).
- Client Recommendation Report
3. Pre-Production Planning
Purpose: Finalize documentation and set up production protocols.
- Final CADs, 2D Drawings, and Specs Review.
- Packaging and Labeling Requirements Document.
- Process Flow Diagram + Control Plan.
- Sample Review Plan (pre-pilot approval or golden sample).
4. Validation: IQ/OQ/PQ Protocols & Execution
Purpose: Create and manage Installation, Operational, and Performance Qualification processes to meet regulatory standards.
- IQ/OQ/PQ Protocols written in alignment with FDA/ISO 13485 standards
- Execution management: coordinate with vendors to perform validation
- Validation summary reports for each protocol phase
- Client sign-off package for traceability and audit readiness
5. Pilot Production & Quality Verification
Purpose: Conduct a controlled production run and verify output quality.
- Pilot Batch Run Samples (typically from validated mold)
- Full Quality Report (dimensions, CPK, surface, function)
- NCR & CAPA Log (if applicable)
- Visual documentation of inspection and packaging
6. Full Production Oversight & Delivery
Purpose: Manage large-scale production, logistics, and final client delivery.
- Production Batch Record Summary.
- Final Documentation Pack (BOM, batch IDs, COA, QC reports).
- Logistics and Delivery Tracking
- Post-Delivery Support Call + Reorder/Support Agreement
Why manufacture with us
With a deep understanding of materials, molding processes, and production techniques, we optimize designs for manufacturability, ensuring high-quality products that are cost-effective to produce.
- Cost Efficiency
- Risk Reduction:
- Comprehensive Support:
What You Get
When you use our design service, you receive tailored solutions that ensure optimal functionality, efficiency, and cost-effectiveness, designed to meet your specific needs.
- Detailed design-for-manufacturing reviews
- Comprehensive material selection and testing
- Rapid prototyping to speed up processes