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Injection Mouldings Oem Manufacturer For Medical Mould Parts for Medtronic 1

Injection Mouldings Oem Manufacturer For Medical Mould Parts for Medtronic 2

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Injection Mouldings Oem Manufacturer For Medical Mould Parts for Medtronic 4

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Injection Mouldings Oem Manufacturer For Medical Mould Parts for Medtronic

We adhere to the strictest quality and regulatory standards in the global healthcare industry, fully complying with ISO 13485, ISO 9001, FDA 21 CFR Part 11, and EU MDR requirements, as well as Medtronic’s internal quality specifications. All our medical mould parts are produced in ISO Class 6 cleanrooms, where we strictly control particulate contamination to meet FDA-mandated levels (＜0.1%), ensuring sterility and cleanliness that exceed operating theater standards. Our production process is fully traceable, from raw material procurement to finished product delivery, with complete documentation of material batches, production parameters, and quality testing results to support Medtronic’s full lifecycle traceability needs.

In terms of precision and craftsmanship, we leverage advanced injection moulding technology and equipment to achieve exceptional accuracy. Our moulds are crafted from medical-grade S136/H13 mold steel, with mirror-polished cavities for sterility and durability, and dimensional tolerances as tight as ±0.001 mm—meeting the ultra-precise requirements of Medtronic’s miniaturized medical components. We master a full range of medical-specific injection moulding processes, including standard injection moulding, insert moulding, overmolding, micro-molding, and thin-wall molding (wall thickness ≤ 1 mm), enabling us to produce complex-shaped parts such as insulin pump housings, catheter connectors, and surgical instrument components with zero flow marks, weld lines, or micro-defects. Our engineers use EDM sinking technology and CAD/CAE simulation tools to optimize mold designs, such as conformal cooling channels, ensuring stable cavity temperatures and eliminating warpage in delicate components like living hinges.

We offer comprehensive OEM customization services tailored to Medtronic’s unique needs. From initial design for manufacturability (DFM) collaboration to rapid prototyping, mass production, and post-processing, our professional team works closely with Medtronic’s engineering department to optimize part performance, reduce production cycles, and control costs. We support customization of material selection, including medical-grade PC, PP, ABS, PPSU, PEEK, and LSR, all of which pass ISO 10993 biocompatibility tests (covering cytotoxicity,致敏性, and irritation) to ensure safety for clinical use. Additionally, we provide flexible production capacity, with monthly output of up to 100,000 pieces, and lead times of 15-40 days, supporting Medtronic’s production scheduling and market demand flexibility.

Our commitment to quality is demonstrated by our zero-field failure record in delivering over 1 million medical components for Medtronic, a testament to our mastery of injection moulding science and strict quality control systems. We conduct multi-layered quality inspections, including microscopic vision system scanning, three-coordinate measurement, and sterilization compatibility testing (adapting to autoclaving, ethylene oxide, and gamma radiation sterilization), ensuring every part meets Medtronic’s rigorous performance and safety standards. As a trusted OEM partner, we prioritize intellectual property protection and maintain strict confidentiality of Medtronic’s design documents and technical specifications throughout the cooperation process.

Partnering with us means accessing a reliable, efficient, and compliant injection moulding solution that aligns with Medtronic’s high standards. We are dedicated to supporting Medtronic’s innovation in medical technology by delivering high-quality, custom OEM medical mould parts, helping enhance the reliability and performance of life-saving medical devices worldwide.

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Shape

Customized Shapes

Cavity

Single Cavity\ Multiple Cavity

Delivery Time

15-30 Days

Logo

Customized Logo

Service

Customized OEM

Color

Customized Colors

Usage

Kitchen

Size

Customer Customized

Certification

ISO9001: 2015

Drawing Format

2D/(PDF/CAD)3D(X_T/STEP)

Plastic Modling Type

Injection

Place of Origin

Guangdong, China

Processing Service

Moulding, Cutting, Develop design production manufacturing shipment

Product Data

Injection Mouldings Oem Manufacturer For Medical Mould Parts for Medtronic 8

Injection Mouldings Oem Manufacturer For Medical Mould Parts for Medtronic 9

No.	Item	Data
1	name	OEM Manufacturer China Product Manufacturing Injection Mouldings for Medical Mould Product Manufactur
2	color	white，black，green，nature，blue，yellow，etc
3	material	ABS,PMMA,PC,PP,PEEK,PU,PA,PA+GF,POM,PE,UPE,PTFE,etc
4	mould cavity	single cavity & multi cavity
5	runner system	hot runner and cold runner
6	equipment	CNC, EDM, cutting off machine，plastic machinery etc
7	mould material	1.2738 420H 1.2767 NAK80 1.2343 1.2344 1.2083 1.0285
8	injection machine	88T, 90T, 120T, 168T, 200T, 380T，420T，1200T
9	mould life	500000-5000000 shots as per customers' requirement
10	size	5-1000mm，or customized
11	tolerance	± 0.01mm
12	shape	as per your drawing or the sample
13	certification	ISO9001 and relate whole set professional test report
14	advantage	one stop procurement
15	Application field	Various plastic injection molded parts for various industrial and automotive applications
16	lead time	15-30 days for mould，plastic products according to quantity
17	other	24 hours instant and comfortable customer service shipping status notification during delivery regular notification of new styles & hot selling styles

Company Introduction

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Fast prototyping within 15 days

Each part meets your specifications and industry standards

Having experienced engineers and skilled production workers