OEM&ODM

Customization Scope

• Branding: logo, name, model, origin, laser engraving, UDI marking • Appearance: housing color, surface finish, material selection • Packaging & Documentation: sterile packaging, multi-language IFU, technical file support • Function: language voice prompts, module combination or removal

Medical OEM & ODM Customization

We are an ISO 13485 / ISO 9001 certified manufacturer offering OEM and ODM services based on our existing medical device platforms.

OEM – Your Brand, Our Proven Products

We apply your branding (logo, name, model, origin) and make modifications according to your requirements on our existing products. Private labeling, packaging and documentation customization available.

ODM – Modify Our Platform to Fit Your Needs

Choose from our existing product range. We support customization of housing color, materials, packaging, user manual, operation panel translation, voice prompts, and module adjustments (e.g., remove screen, combine different components).

Compliance & Quality

ISO 13485:2016

ISO 9001

CE (MDD/MDR)

FDA establishment registration

Clean room production

Full traceability

NDA protection

Workflow

Inquiry

Feasibility & Quotation

Sample Modification