OEM/ODM Process: From Inquiry to Product¶
This page outlines the OEM/ODM process at Migibio — the stages from initial inquiry to delivered product.
The Process¶
| Stage | What happens |
|---|---|
| 1. Inquiry | Define requirements, target market, volumes |
| 2. Specification | Assay menu, branding, packaging, regulatory needs |
| 3. Sampling & validation | Provide samples; validate performance |
| 4. Agreement | Terms, MOQ, pricing, timelines |
| 5. Production | Manufacturing under ISO9001/GMP |
| 6. Delivery & support | Shipment, training, documentation |
Documentation at Every Stage¶
- Validation reports — analytical performance of your products.
- COA per lot — lot-specific performance.
- IFU — instructions for your branded products.
- Regulatory dossiers — support for market registration.
Timeline Considerations¶
| Factor | Impact on timeline |
|---|---|
| Standard OEM (existing assay) | Faster — reuses validated assays |
| Custom ODM (new specification) | Longer — requires R&D + validation |
| Regulatory registration | Market-dependent |
FAQ¶
How long does OEM take? Standard OEM (existing assays, your brand) is faster; custom ODM requires additional R&D and validation time. Contact [email protected] for current estimates.
Can you support regulatory registration in my market? Yes — regulatory documentation and dossier support are part of the partnership.
For model selection, see Partnership Models.
Authored by: Migibio Clinical & Scientific Affairs, Guangzhou Magic Biotech Co., Ltd.
Reviewed by: Migibio R&D Quality Committee
Last updated: 2026-08-13
Disclosure: Migibio (Guangzhou Magic Biotech Co., Ltd.) is the manufacturer of the FIA680/FIA880 analyzers and FICT reagents referenced in this content. See our Editorial & Review Policy.