医療グレード OEM／ODM／EMS／CM ソリューション｜専門医療機器製造サービス｜Onyx Healthcare

信頼できるコンプライアンス対応の医療製造パートナー

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.

Our Manufacturing Services

Clinic Chemical Analyzers

Custom controller and UI design optimized for clinical and laboratory workflows.

Endoscopy Systems

Integrated imaging engines and displays that enhance diagnostic clarity and system reliability.

Physiological Signal Acquisition Systems

Multi-channel biosignal capture and monitoring with medical-grade accuracy and stability.

Medical Software Storage & Transmission Systems

Secure, high-speed data storage and communication platforms that meet healthcare compliance.

Medical Computing Platforms

From bedside terminals to OR workstations, engineered for medical safety, durability, and performance.

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.