OEM Service for Interventional Medical Devices

Backed by a 12,000㎡ GMP-compliant manufacturing base and in-house R&D capabilities, MicroApproach Medical is a trusted OEM/ODM partner for global interventional device brands.

We offer end-to-end custom solutions—from product design and material selection to pilot runs and mass production—specializing in guidewires, catheters, and minimally invasive interventional consumables built to rigorous international quality standards.

OEM Process

Concept & Design

Submit your concept, drawings, or samples. Our R&D team performs feasibility analysis, design optimization, and DFM review for guidewires and catheters.

Mold & Prototyping

In-house mold design and CNC machining. Functional prototypes (ground wires, tipped catheters, coated samples) delivered rapidly for verification.

Process Validation

Comprehensive IQ/OQ/PQ validation prior to mass production.

Mass Production

Automated extrusion and hydrophilic coating lines. Strict QC ensures batch consistency.

Delivery & Support

On-time global delivery with sterile/non-sterile packaging, complete batch documentation, and post-market technical support.

Quality & Regulatory Support

Core Expertise

Precision-driven R&D and manufacturing across guidewires, catheters, sheath introducers, and interventional accessories.

Advanced Mold Shop

In-house CNC machining center enabling high-precision mold design and rapid tooling for complex micro-components.

Surface Technology

Proprietary hydrophilic coating and tip-molding technologies ensuring superior lubricity, trackability, and optimal distal flexibility.

Testing & Validation

In-house physical, mechanical and biological testing—including guidewire torque, catheter pressure and coating adhesion—plus third-party biocompatibility verification to fully comply with ISO 13485requirements.

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14 Jinhui Road, Pingshan District, Shenzhen,518122, P.R.China

+86-755-89459010

+86-18320758765 Ares

+86-15013496274 Daisy

+86-15813727825 Gloria

+86-13686827432 Sally

sales@microapproachmed.com