OEM / ODM SERVICES
IVD OEM and ODM Manufacturing Services
Your partner for private-label rapid diagnostic tests. From custom branding and packaging to documentation support, we deliver complete OEM/ODM solutions for distributors and brand owners worldwide.
Why Partner With PRISES
Private Label Solutions
Your brand, your packaging, our manufacturing. We produce rapid diagnostic tests under your private label with custom artwork, inserts and multi-language support.
Custom Box Design
Your brand identity on the outer packaging: logo, colors, product name and regulatory markings per your market requirements.
Branded Labels
Device labels and pouch labels featuring your brand, lot number, expiry date and any required symbols.
Custom Inserts & IFU
Instructions for use (IFU) and package inserts designed with your branding and translated into your target languages.
Multi-Language Artwork
Packaging and documentation in multiple languages for distribution across different markets.
Confidential Manufacturing
Your brand stays yours. We manufacture under your label with full confidentiality — you market, we produce.
Regulatory Alignment
Packaging designed to meet the labeling requirements of your target market, with appropriate symbols and declarations.
How Private-Label Works
Share Your Brand Guidelines
Provide your logo, brand colors, product naming and any specific design requirements.
Artwork Development
Our design team creates packaging artwork based on your brand identity and regulatory requirements.
Approval & Production
Once you approve the artwork proofs, we proceed to production with your branded packaging.
Packaging Customization
Configure rapid test products to your exact specifications: format, panel configuration and packaging options tailored to your market requirements.
Packaging Options
Product Development Process
A clear, five-step process from initial inquiry to global export. We guide you through each stage, from sampling and customization to production and delivery.
Inquiry & Consultation
Share your product requirements, target market and estimated volume. Our team will assess feasibility and provide initial guidance on formats, specifications and regulatory considerations.
Sampling & Customization
We prepare product samples and custom packaging proofs for your review and approval. This stage includes artwork design, format selection and any specification adjustments.
Quotation & Agreement
Transparent pricing and clear commercial terms. Once samples are approved, we finalize pricing, payment terms and production schedule.
Production & Quality Control
Manufactured under ISO 13485 quality management with full in-process QC. Each batch undergoes inspection and release testing before packaging.
Packaging & Global Export
Your branded products are packed according to your specifications and shipped to your destination. We support export documentation for smooth customs clearance.
Documentation Support
We provide documentation to support your product import and registration. Technical files, product dossiers and export certificates prepared for your market requirements.
CE Documentation
CE marking documentation including Declaration of Conformity, technical documentation summaries and relevant test reports.
Technical Files
Product technical files containing design specifications, manufacturing processes, quality control procedures and validation data.
Product Dossiers
Comprehensive product dossiers compiled to support registration submissions in various markets.
Instructions for Use (IFU)
Product instructions in your required languages, formatted to meet labeling requirements of your target market.
Certificate of Free Sale
Certificates confirming that products are freely sold in the country of manufacture, often required for import registration.
ISO & Quality Certificates
Copies of ISO 13485 certification, NMPA manufacturing license and other quality system documentation.
OEM and ODM FAQ
Common questions about customization, orders and partnership.
Start Your OEM Project
Contact us to discuss your requirements and get a quotation.