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

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.
Why Partner with Onyx?
Working with ONYX Brings You:
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.
Contact us to take the next step in your medical innovation journey:
Sales@onyx-healthcare.com