ISO 13485 custom medical device injection molding, Engineering Expertise, Near Shore Supply Chain Reliability
Mission Plastics is an ISO 13485 certified custom medical device plastic injection molding manufacturer specializing in precision components for regulated healthcare and medical device applications. We provide class 8 cleanroom manufacturing capabilities, all around tooling support, engineering services, and validated production processes for OEMs requiring consistent quality, traceability, and supply chain reliability. Our core focus is helping customers manufacture high-performance plastic components that meet demanding regulatory, functional, and cosmetic.
Injection molding production is performed exclusively at our Mexicali, Baja California facility, while tool rooms, quality, engineering, program management, customer service, and production planning resources are located in both, Mexicali and Rancho Cucamonga, CA. This dual site support model ensures strong on site manufacturing execution in Mexico combined with responsive customer facing coordination and technical oversight from the United States.
Mission Plastics supports customers throughout the full product lifecycle, from early design and development through validated production and long-term manufacturing. Our teams work collaboratively with customers to optimize designs for manufacturability, improve process stability, and reduce overall program risk. We serve medical device OEMs seeking a dependable nearshore manufacturing partner with proven technical depth and disciplined execution.
Medical Device Injection Molding and Cleanroom Manufacturing
Mission Plastics specializes in medical device injection molding for components used in diagnostic, therapeutic, and healthcare applications. Our Mexicali manufacturing facility supports a wide range of press tonnages and includes ISO Class 8 cleanroom molding environments for products requiring controlled conditions. We mold medical-grade thermoplastics commonly used in regulated applications, supporting both disposable and reusable medical device components.
Our injection molding processes are designed for repeatability, dimensional stability, and cosmetic consistency. We support low to high volume production programs and work closely with customers to maintain validated processes throughout the life of the product. By combining controlled manufacturing environments with disciplined process management, Mission Plastics helps ensure reliable performance in critical medical applications.
Engineering, Tooling, and Design for Manufacturability
Engineering and tooling expertise are central to Mission Plastics’ manufacturing approach. Engineering teams in both locations provide design for manufacturability support, process development, and technical problem solving. We work closely with customers during early design stages to evaluate part geometry, material selection, gating strategies, and tooling concepts that support efficient and repeatable injection molding.
Tool rooms in both locations support mold builds, maintenance, and continuous improvement activities. This dual-location tooling capability allows for responsive support, reduced downtime, and consistent mold performance. Our engineering-led approach helps customers reduce costly design revisions and achieve smoother transitions from development into full production.
Validation, Quality Systems, and Process Control
Mission Plastics operates under ISO 13485 certified quality systems designed to support regulated medical device manufacturing. We provide full process validation services, including IQ, OQ, and PQ, to ensure molding processes are properly qualified and controlled. Quality and engineering teams work together to establish robust process controls, inspection plans, and documentation aligned with customer and regulatory requirements.
Ongoing production is supported by disciplined quality monitoring, preventive maintenance programs, and continuous improvement initiatives. Our focus on validation and process control helps customers maintain compliance, reduce risk, and ensure consistent product quality over time.
Nearshore Manufacturing and Program Support
Mission Plastics’ nearshore manufacturing model combines production in Mexicali with technical and customer facing support in the United States. Program management, customer service, and production planning resources are available in both locations, enabling effective coordination across engineering, manufacturing, and quality functions.
This structure allows customers to benefit from cost effective nearshore production while maintaining close communication, transparency, and accountability. Mission Plastics supports supply chain resilience by offering predictable lead times, responsive issue resolution, and long-term manufacturing stability for medical device programs.
Value-Added Manufacturing and Assembly Services
In addition to injection molding, Mission Plastics provides value-added manufacturing services to support complete component or sub-assembly solutions. These services may include secondary operations, assembly, inspection, labeling, and packaging tailored to customer requirements. By consolidating manufacturing steps within a single supply partner, customers can reduce complexity and improve overall program efficiency.
Our value-added capabilities are integrated into validated manufacturing processes, ensuring quality and traceability are maintained throughout production. Mission Plastics works closely with customers to align secondary operations with regulatory and performance expectations.
Please use the form to send us your business enquiry and discuss your medical device injection molding or cleanroom manufacturing requirements with our team.
Press Releases
Mission Plastics at the Manufacturing & Supply Chain Nearshoring Summit – Booth #29
Mission Plastics will be exhibiting at the Manufacturing & Supply Chain Nearshoring Summit 2026 in El Paso, Texas, October 21–22, 2026. Come find us at Booth #29.Mission Plastics at BajaMak 2026 – Booth #219
Mission Plastics will be exhibiting at BajaMak 2026 in Tijuana, Mexico, on October 22, 2026. Come find us at Booth #219.Nearshore Manufacturing Emerges as a Strategic Advantage for Companies Seeking Supply Chain Reliability
As companies continue to evaluate the risks and costs associated with overseas production, nearshore manufacturing is gaining momentum as a strategic solution for improving supply chain reliability, responsiveness, and total value.Contact us
- www.missionplastics.com
- information@missionplastics.com
- 909-821-1518
-
10310 Regis Ct
Rancho Cucamonga, CA
91730
United States














