EnglishCapabilities
We are dedicated to providing you with efficient and meticulous service and tailor-made solutions.
We are dedicated to providing you with efficient and meticulous service and tailor-made solutions.
Wongeny provides clients with comprehensive one-stop solutions, from lab-scale to industrial automation, covering every stage from design, prototyping, validation to pilot production, scale-up testing, and mass production. Our team is driven by efficiency, helping clients realize their high-precision ideas.
Contact Wongeny today to begin exploring your CDMO service needs in the medical device field.
After you get in touch with Wongeny, we sign a non-disclosure agreement (NDA) before proceeding. This is to protect the confidentiality of your information. Once signed, we will have a call with you to introduce ourselves and our capabilities and discuss your design, timeline, and production volume.
Ready to get started? Get in touch with Wongeny to start a conversation with our team about your needs.
The project manager coordinates an internal review to confirm the user requirement specification, ensuring that scope, performance, compliance, and delivery expectations are clearly defined before development begins.
Our project team aligns responsibilities, communication routes, milestones, risks, and deliverables with the client at the formal project kick-off meeting.
Mechanical, electrical, software, and process concepts are integrated into a complete system architecture for review and approval.
A detailed quotation is prepared based on the confirmed technical solution, project scope, component selection, validation requirements, and delivery schedule.
The final development plan defines project phases, review gates, resource allocation, quality controls, documentation, and target completion dates.
Our engineers complete detailed mechanical design, component selection, tolerance analysis, manufacturability review, and assembly planning.
Electrical architecture, control systems, safety circuits, wiring, sensors, and interfaces are designed and documented for implementation.
The multidisciplinary team reviews the complete design against the approved URS, applicable standards, technical risks, and verification strategy.
Approved drawings, bills of materials, and technical documents are released for manufacturing, machining, and qualified external sourcing.
Procurement orders are placed with approved suppliers, with lead times, quality requirements, traceability, and incoming inspection criteria controlled by the project team.
Wongeny offers rapid lead times and unique manufacturing capabilities, enabling us to produce high-quality medical devices and provide CDMO services. Our extensive expertise and efficiency-driven approach help clients achieve their high-precision ideas.
Wongeny will work with you to utilize locally-sourced materials when possible to cut down on costs while continuing to meet the quality standards required for medical devices.
Wongeny can create prototype molds in 1-2 weeks once the design is locked. We can create production molds in 4-6 weeks, depending on design complexity.
Our goal is to provide you with the best possible product. We manage the entire supply chain, including everything from design to distribution.
Wongeny is able to ramp up from 0 to 2 million parts/month in 2 months. This is a difficult feat. However, Wongeny has the experience and expertise to make this happen.
