Customization Injection Moldin Project Medical Application Plastic Part Development for Siemens Healthineers
We strictly adhere to the most rigorous quality and regulatory standards governing the global medical device industry, fully complying with ISO 13485:2016, ISO 9001:2015, EU MDR 2017/745, and FDA 21 CFR Part 820 requirements, as well as Siemens Healthineers’ internal strict quality specifications and statutory flowdown provisions for OEM partners. All medical plastic parts are developed and produced in ISO Class 7 (10,000) certified cleanroom facilities, with strict control over particulate contamination and environmental parameters to ensure sterility and cleanliness that meet the demanding standards of medical imaging and diagnostic equipment. We implement a full-lifecycle traceability system, covering raw material procurement, molding process, quality testing, and final delivery, with complete documentation of material batches, production parameters, and inspection results to support Siemens Healthineers’ audit readiness and recall management needs.
Our customization injection project and plastic part development process are fully aligned with Siemens Healthineers’ equipment requirements, emphasizing precision, material compatibility, and functional reliability. Leveraging advanced CAD/CAE simulation tools and EDM sinking technology, our engineering team optimizes mold design and injection molding parameters to achieve exceptional dimensional accuracy, with tolerances as tight as ±0.001 mm—perfectly matching the miniaturized and complex design needs of Siemens Healthineers’ medical equipment components. We specialize in a full range of medical-specific injection molding processes, including standard injection molding, insert molding, overmolding, and micro-molding, enabling the development of diverse plastic parts such as MRI local coil housings, CT scanner connectors, ultrasound probe casings, diagnostic instrument enclosures, and interventional radiology component covers. All molds are crafted from high-grade medical mold steel (S136/H13) with mirror-polished cavities, ensuring durability, sterility, and consistent part quality across mass production batches.
We offer end-to-end customization development services, partnering closely with Siemens Healthineers’ engineering team from the initial design for manufacturability (DFM) stage to prototype development, mold fabrication, mass production, and post-processing. Our team of materials scientists and injection molding experts assists in selecting the optimal medical-grade plastic materials, including PC, PP, ABS, PEEK, PPSU, and acrylics—all of which pass ISO 10993 biocompatibility tests (covering cytotoxicity, irritation, and sensitization) and meet the specific performance requirements of Siemens Healthineers’ equipment, such as radiological transparency for imaging components and resistance to sterilization (autoclaving, ethylene oxide, gamma radiation). For flexible components like MRI local coils, we leverage ultrasound welding technology to ensure pliability and patient comfort, while maintaining structural integrity and non-imaging interference properties critical for diagnostic accuracy.
Quality control is embedded in every stage of our development and production process, ensuring that every plastic part meets Siemens Healthineers’ rigorous performance and safety standards. We conduct multi-layered inspections, including three-coordinate measurement, microscopic vision system scanning, material composition testing, and sterilization compatibility testing, with a zero-defect objective for all delivered parts. Our project management team is experienced in handling complex timelines and deadlines, ensuring seamless coordination with Siemens Healthineers’ production schedules, with flexible production capacity (monthly output up to 100,000 pieces) and lead times of 15-45 days to support rapid product launch and market demand flexibility. We also prioritize intellectual property protection and maintain strict confidentiality of Siemens Healthineers’ design documents, technical specifications, and project details throughout the cooperation process.
As a trusted customization injection project and plastic part development partner for Siemens Healthineers, we are committed to driving innovation and efficiency in medical equipment manufacturing. Our expertise in regulatory compliance, precision injection molding, and customer-centric customization enables us to deliver high-quality plastic parts that enhance the performance, reliability, and patient-friendliness of Siemens Healthineers’ medical devices, contributing to the advancement of global healthcare.
5.0
design customization
Please fill out the form below to request a quote or to request more information about us. Please be sure to upload customized requirement documents or pictures, and we will get back to you as soon as possible with a response. we're ready to start working on your new project, contact us now to get started.
Please fill out the form below to request a quote or to request more information about us. please be as detailed as possible in your message, and we will get back to you as soon as possible with a response. we're ready to start working on your new project, contact us now to get started.
Plastic Material
ABS/PP/PS/PE/PVC/PA6/PA66
Surface
Smooth
Mold Material
1.2738 P20 1.2343 1.2344 1.2083 1.2085 8407 1.2767
Certificate
ISO9001:2015
Product name
electronic products
Features
Light Weight
Logo
Customized Logo Availabled
Color
Customer Requirement
Size
Customized Size
Drawing Format
3D.STP. STEP . IGS . PRT . X_T
Plastic Modling Type
Injection
Place of Origin
Guangdong, China
Processing Service
Moulding
Product Data
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No.
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Item
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Data
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1
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name
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Medical Application Plastic Part Development & Customization Injection Molding Injection Manufacturing Plastic Mold Project
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|
2
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color
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white，black，green，nature，blue，yellow，etc
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3
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material
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ABS,PMMA,PC,PP,PEEK,PU,PA,PA+GF,POM,PE,UPE,PTFE,etc
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4
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mould cavity
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single cavity & multi cavity
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5
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runner system
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hot runner and cold runner
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6
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equipment
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CNC, EDM, cutting off machine，plastic machinery etc
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|
7
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mould material
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1.2738 420H 1.2767 NAK80 1.2343 1.2344 1.2083 1.0285
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8
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injection machine
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88T, 90T, 120T, 168T, 200T, 380T，420T，1200T
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9
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mould life
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500000-5000000 shots as per customers' requirement
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10
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size
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5-1000mm，or customized
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11
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tolerance
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± 0.01mm
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12
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shape
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as per your drawing or the sample
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13
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certification
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ISO9001 and relate whole set professional test report
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14
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advantage
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one stop procurement
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15
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Application field
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Various plastic injection molded parts for various industrial and automotive applications
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16
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lead time
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15-30 days for mould，plastic products according to quantity
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17
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other
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24 hours instant and comfortable customer service
shipping status notification during delivery
regular notification of new styles & hot selling styles
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Company Introduction
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