Full Standard OEM & Private Label Customization Process For Disposable Medical Electrodes

Published: JULY 27, 2026 - Shanghai Zhichen Medical Technology Co., Ltd.

Many overseas medical device brand owners choose to entrust domestic factories to complete OEM/ODM customized production of ECG, TENS and neutral electrodes, including exclusive formula adjustment, private label packaging and certification document matching. This article sorts out the complete standardized customization process and customer preparation materials.

1 Preliminary Demand Communication & Parameter Confirmation

1.1 Core Product Selection

Confirm product type: clinical single-use ECG pad / reusable TENS pad / surgical neutral grounding plate; confirm target market to match corresponding certification standards (FDA / CE MDR).

1.2 Key Technical Custom Items

• Electrode shape, length, width and snap position
• Ag/AgCl or carbon conductive layer selection
• Hydrogel: hypoallergenic single-use / multi-cycle reusable formula
• Target impedance range and skin irritation standard

1.3 Packaging Custom Requirements

Private brand LOGO, multi-language instruction text, outer carton size, EO breathable composite film material.

2 Sample Production & Customer Confirmation

Arrange small trial production according to confirmed parameters

Complete electrical performance and viscosity internal test

Send physical samples + test data sheet to customer

Collect customer revision feedback, adjust formula or size for secondary samples

Lock final sample as mass production standard reference

3 Mold Opening & Tooling Customization

If the customer’s exclusive size cannot be covered by existing molds, open a new rotary die-cutting mold. After mold trial cutting, check whether the electrode outline and snap hole position are consistent with the sample, and archive the mold drawing for exclusive use by the brand.

4 Packaging Graphic Design & Plate Making

Customers provide brand AI vector files; design single pouch and outer carton layout according to market regulatory text requirements; after customer graphic confirmation, arrange printing plate production to avoid color difference in batch packaging.

5 Raw Material Scheduling & ISO13485 Batch Production

5.1 Raw Material Preparation

Purchase matched substrate, conductive snap and customized hydrogel according to order quantity, and complete incoming batch inspection records.

5.2 Cleanroom Mass Production

Full-process production in 100k dust-free workshop, real-time recording of each process batch number to realize full traceability of OEM products.

5.3 Finished Batch Inspection

Carry out sampling inspection according to unified AQL standard, and deliver only after all electrical and appearance indexes pass.

6 EO Sterilization & Packaging Sealing

After batch production, enter ethylene oxide low-temperature sterilization cycle, complete aeration degassing, and then carry out private label independent sealing and outer carton grouping coding.

7 Certification Document Supporting Service

Provide complete ISO10993 biocompatibility test report, ISO13485 certificate, raw material qualification file, sterilization record and other supporting documents required for overseas customer registration.

8 Minimum Order Quantity & Delivery Cycle Reference

Existing standard mold OEM: MOQ 50,000 pcs, delivery 7-10 working days

New mold exclusive customization: MOQ 100,000 pcs, delivery 15-20 working days

Separate private label packaging customization: additional 3-5 days printing cycle

Summary

Standardized OEM customization process realizes one-stop service from demand communication, sample trial production, mold development to batch production and certification supporting, which saves overseas brand buyers multiple links of coordination and shortens product launch cycle.