Onyx QMS-Certified Quality × Flexible Manufacturing Models to Power Your Medical Success

June 30, 2025

Onyx QMS-Certified Quality × Flexible Manufacturing Models

Why Partner with Onyx?

In today’s increasingly regulated healthcare landscape, choosing a manufacturing partner with certified quality management systems is critical to launching compliant, high-performing medical products.

Onyx Healthcare is certified under a comprehensive QMS(GMP) framework, including ISO 13485, ISO 9001, FDA QSR, CE, and IEC 60601. With this foundation, we offer flexible manufacturing solutions—Contract Manufacturing (CM), OEM, and ODM—that support global medical clients with reliable, high-quality, and scalable production services.

International QMS Certification & Rigorous Manufacturing Processes

Certified to ISO 13485 (Medical Device Quality Management) and ISO 9001
In-depth knowledge of FDA QSR, CE, UL, IEC 60601 medical safety standards
From design to mass production, all workflows follow standardized, traceable QMS protocols

Medical Focus with Clinical Understanding

Over 15 years of experience dedicated solely to medical device manufacturing
Proven capabilities across smart wards, mobile nursing, AI-powered diagnostic platforms, and more
All products are designed with dual focus: regulatory compliance and real-world clinical utility

Flexible Collaboration Models for Every Business Stage

Core strength in CM, with options for OEM and ODM depending on your resource and design needs
Whether you have a finalized design, detailed specifications, or just a product idea—we can collaborate from any point

Certified Quality Assurance

QMS-governed processes ensure compliance with global medical regulations and standards

Efficient and Flexible Production Models

Scalable to fit your volume, customization, and integration needs

Accelerated Time-to-Market

Integrated design, regulatory, production, and testing support speeds up your go-to-market roadmap

Global Technical Support with Integrated Manufacturing

Taiwan-based manufacturing combined with localized support across the U.S., Europe, and Asia

Let’s Build the Future of Healthcare—Together

Whether you're developing a next-generation smart medical device or enhancing an existing solution, ONYX’s CM/OEM/ODM services offer the precision, compliance, and partnership you need.
We don’t just manufacture hardware—we help you create differentiated value and market advantage.

相關標籤

#MedicalDevices
#QMS
#ISO13485
#ContractManufacturing
#OEM
#ODM
#HealthcareInnovation
#OnyxHealthcare
#MedicalComputing