Medical Device Injection Molding

Uncompromising quality for life-critical innovations. JUCHENG offers ISO 13485 certified medical device injection molding services, operating within a controlled ISO Class 8 cleanroom environment to ensure the highest levels of purity for medical grade plastic manufacturing.

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IATF 16949 / ISO 13485 / ISO 14001 VALIDATED

Specialized Medical Molding

Combining advanced materials science with precision engineering.

High-Performance PEEK

Machining and molding biocompatible PEEK for spinal cages and orthopedic implants. Our oil-heated molds ensure 100% crystallization for maximum strength.

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Micro-Molding

Producing sub-gram components for minimally invasive surgical tools and microfluidic testing arrays with sub-millimeter features.

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Overmolding / 2K

Fusing soft-touch TPE or medical-grade Silicone onto rigid PEEK or Stainless Steel handles for superior surgical ergonomics and non-slip performance.

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The Foundation of Medical Quality

Micron-Level Tooling

Utilizing our 25+ in-house 5-axis CNC machines, we cut medical mold cavities to sub-micron tolerances, eliminating flash that could otherwise lead to particulate shedding in surgical tools.

SPI A-1 Polishing

Our toolmakers achieve diamond-grade mirror finishes on mold surfaces, essential for diagnostic components where optical clarity dictates the accuracy of medical test results.

Zeiss CMM Metrology

Every critical medical dimension is verified by Zeiss Coordinate Measuring Machines. We provide detailed FAI and CPK reports to support your FDA and CE regulatory submissions.

Rapid Bridge Tooling

Accelerate clinical trials. We build high-precision aluminum or soft-steel "bridge tools" in-house in as fast as 10-15 business days, allowing for functional testing in production-grade resins.

Sterile Manufacturing Strategy

Medical devices demand more than just dimensional accuracy; they require a controlled environment to mitigate bio-burden and particulate risks. Our ISO Class 8 Cleanroom is the heart of our medical operations.

By utilizing all-electric injection presses, we eliminate oil-mist contamination, providing a pristine environment for transparent optics and fluid-delivery components. Every project is backed by full lot traceability and material certifications (USP Class VI / ISO 10993).

Medical Grade Material Matrix

Our medical device injection molding services focus on biocompatible plastic components. We excel in surgical instrument molding and orthopedic device plastic manufacturing, providing 100% lot traceability from resin to final delivery.

Material Category	Specific Resin	Medical Feature	Sterilization Compatibility
High-Performance	PEEK / PEI (Ultem)	Biocompatible / Radiolucent	Autoclavable, Gamma, EtO
Optical / Clear	COP / PC / PMMA	Extreme Clarity / High Flow	EtO, E-Beam
Flexible / Seals	LSR / TPE	USP Class VI / Non-Toxic	Autoclavable, Gamma
Engineering	PA66 / POM / PBT	High Strength / Low Friction	EtO, Gamma

Critical Applications

Diagnostics & Microfluidics

We mold optically clear components using COP and PC in our cleanroom. These parts are critical for blood analysis and molecular diagnostics, requiring zero dust inclusions and high UV transmission.

Orthopedic & Surgical

Manufacturing of high-strength PEEK targeting guides and surgical handles. Our 5-axis mold making allows for complex ergonomic shapes that fit perfectly in the surgeon’s hand.

Bring Your Medical Innovation to Life

Upload your CAD files today for a free, confidential DFM analysis by our medical manufacturing engineers. ISO 13485 compliant quotes delivered within 24 hours.

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