Medical-Grade OEM / ODM / EMS/ CM Solutions | Professional Medical Device Manufacturing Services | Onyx Healthcare

Trusted Partner for Compliant Medical Manufacturing

Onyx Healthcare is your trusted OEM / ODM / EMS/ CM partner for medical-grade solutions

offering one-stop services from design and prototyping to certified mass production. With ISO 13485-certified QMS and full regulatory compliance, we transform your ideas into reliable and market-ready medical devices.

One-Stop Medical ODM / EMS Expertise

Medical Expertise

Over 15 years of experience in medical computer and device manufacturing with full regulatory knowledge.

Integrated Engineering

In-house motherboard, thermal, mechanical, and software design capabilities.

Quality Commitment

ISO 13485, ISO 9001, ISO 14001 certified facilities with traceable QMS systems.

Flexible Production

From small-batch prototyping to high-volume manufacturing.

Global Reach

Service and support centers in the U.S., Taiwan, and Europe.

Nuestros Servicios de Fabricación

Analizadores Químicos Clínicos

Diseño personalizado de controladores e interfaces de usuario optimizado para flujos de trabajo clínicos y de laboratorio.

Sistemas de Endoscopia

Motores de imagen y pantallas integrados que mejoran la claridad diagnóstica y la fiabilidad del sistema.

Sistemas de Adquisición de Señales Fisiológicas

Captura y monitoreo multicanal de biosignales con precisión y estabilidad de grado médico.

Sistemas Médicos de Almacenamiento y Transmisión de Software

Plataformas seguras y de alta velocidad para almacenamiento de datos y comunicación, cumpliendo con las normativas del sector salud.

Plataformas de Computación Médica

Desde terminales junto a la cama del paciente hasta estaciones de trabajo para quirófano, diseñadas para ofrecer seguridad médica, durabilidad y alto rendimiento.

Quality & Compliance

We follow international medical manufacturing standards to ensure compliance and reliability:

ISO 13485:2016 Medical Device QMS
ISO 9001:2015 Quality Management System
FDA QSR (Quality System Regulation)
IEC / UL 60601 Safety Compliance

Our digital QMS traceability system guarantees full visibility across every production stage.

Manufacturing Capabilities

Cleanroom Environment
ISO 5 / ISO 6 certified facilities for contamination-free medical assembly.
Comprehensive Testing
Functional, environmental, EMC/EMI, and aging verification for reliability.
Digital QMS Platform
Real-time monitoring and version traceability for total quality assurance.

One-Stop Medical Manufacturing Expertise

Project Planning & Medical Compliance
Design Engineering for Clinical Use
Testing & Regulatory Verification
Collaboration & Integrated Solutions
Scalable Manufacturing & Quality Control
QMS Support & Long-Term Reliability

Success Stories

We have partnered with leading global brands to turn medical innovation into commercial success:

Co-developed AI medical imaging systems with CE/FDA certification.
Onyx’s regulatory expertise made our product launch seamless.

Contact

Contact our professional OEM/ODM/EMS/CM team today. From prototype to mass production, we deliver compliant, reliable, and efficient medical device manufacturing solutions.