Medical Molding
Optimize complex designs, shorten development cycles, access seamless global production, and ensure quality with Enplas medical injection molding.
Medical Injection-Molded Plastic Products at All Stages
We manufacture life sciences products at all levels: custom components, such as single-use disposables, microfluidic chips, elastomer fluid seals, diagnostic cartridge housings, bioprocessing connectors, and more in our state-of-the-art ISO 13485-certified Class 7 cleanroom.
Our vertically integrated production facility can accelerate your new or existing medical product’s speed-to-market with design development (DFM), mold design, in-house mold build, cleanroom medical injection molding and assembly, and QA all under one roof. We stay by your side through the entire process.
Enplas Medical Injection Molding Quality: A Proactive Approach You Can Trust
Certification and Quality Management
Our high standards ensure that you receive the quality products you need. Enplas is ISO 13485-certified and operates a robust QA program catering to the medical industry. We use industry-standard process validation, including FMEA, scientific molding processes and DQ, IQ, OQ, and PQ for medical molding. All injection molding and assembly is conducted in our Class 7 cleanroom. We use state-of-the-art machinery for quality inspections.
Precision Mass Production
Whether you need your product manufactured at high or low volumes, our precision mass production team ensures that our molds and injection molding process always result in consistent quality for your product. All of our molds are built in-house with close coordination among our engineers. Our tooling department uses state-of-the-art equipment to build high precision and tight tolerance medical molds (SPI class 101-102) and provide expert mold maintenance. We have deep expertise in overmolding thermoplastic elastomers (TPE). Value-added assembly, such as thermo-bonding, are also available.
Delivery
We understand that consistent, timely delivery of your product is critical. Customers benefit from our global supply chain. You’ll always be kept informed on your project’s status with regular updates.
Learn more about how our global supply chain ensures on-time delivery of your product.
Stress-Free, Dedicated Support for Development, Prototyping, and Mass Manufacturing
Flexibility & Support
Your project may change—we understand. We routinely support customers like you that are developing solutions to meet routine, critical, or unmet healthcare needs, no matter how many iterations it takes. Our production-grade prototype molds are robust enough to provide consistent quality parts, while still open for revisions if necessary. Many times, we can help speed up your product development process.
Speak with our sales team about how we can support your project.
Production-Grade Prototyping
We can help bridge your transition from soft-tool “rapid prototyping” to mass production of your product. Our production-grade prototype tools provide high-quality samples and initial production runs, avoiding inconsistent parts and the unnecessary iterations commonly found with soft-tooling prototypes.
Design for Manufacturability
We offer full engineering services including tool designs, tolerance studies, mold flow analysis and more. Our expertise in DFM principles ensure that your part designs and material choice are optimal for both stable medical injection molding and assembly with surrounding components. Learn more about our DFM process here and here.