Comprehensive OEM/ODM Solutions
SGO Medical provides full-service OEM and ODM manufacturing capabilities for medical device companies worldwide. With over 20 years of experience in precision medical device manufacturing, we serve as a trusted production partner for startups, SMEs, and multinational corporations across 50+ countries.
Our OEM Services
Bring your existing designs to production with confidence. Our OEM services include:
- Design for Manufacturing (DFM) optimization to reduce costs and improve producibility
- Prototype development and design verification testing (DVT)
- Process validation (IQ/OQ/PQ) compliant with FDA 21 CFR Part 820
- Scaled production from low-volume (100 units) to high-volume (1M+ units) annually
- Custom packaging and private labeling to your brand specifications
- Complete device history record (DHR) documentation for each production lot
Our ODM Services
Leverage our engineering expertise to develop new products from concept:
- Market research and product feasibility analysis
- Industrial design and mechanical engineering
- Electrical and embedded systems design
- Biocompatibility testing and materials selection
- Risk management documentation (ISO 14971)
- Clinical evaluation report (CER) preparation
Quality Commitment
Every product manufactured at SGO undergoes rigorous quality control processes. Our QMS is certified to ISO 13485:2016, and our facilities are registered with the FDA, CE Notified Body, and NMPA. We maintain full traceability from raw materials to finished goods, with statistical process control (SPC) monitoring on all critical dimensions.
Case Studies
We have successfully delivered over 200 OEM/ODM projects, including surgical instruments for a Fortune 500 medical device company, diagnostic equipment for a Japanese healthcare conglomerate, and rehabilitation devices for a European startup that achieved CE marking within 18 months of project initiation.