ONYX Healthcare USA Service Center Receives ISO13485 Certification

ONYX Healthcare USA Inc., a FDA registered medical computing platform manufacturer, receives ISO13485 certification for its North America service center.

ONYX Healthcare USA, Inc. (ONYX) – the leading solution provider for medical grade computing platform has always committed to providing state-of-the-art medical technology and high-quality design manufacturing service to top tier medical device companies servicing the hospitals and clinics around the world. 

To expand its service capability and expedite technical support response time, ONYX has submitted its North America service center located in Orange, CA to DNV for ISO13485 certification.

These certifications include the following:

  • The International Standard EN ISO 13485:2003, which specifies the requirements for a quality management system to service medical certified product; and
  • The ISO 9001:2008, which requires that a quality management system be able to consistently enhance customer satisfaction through effective system application;

ONYX’s medical grade products with UL60601 certification are often integrated into major Medical Device Company’s FDA certified solutions that are deployed throughout different healthcare facilities.  In order to minimize service down time within the healthcare facilities, quality management process within ONYX’s North America Service Center must be certified with ISO13485 quality management practice to provide quality service towards medical grade technology domestically. 

By investing resources to maintain ISO13485 certification and FDA Registration, ONYX continually demonstrates its commitment to innovative product development, customer safety, and quality system application for the healthcare sector.

“ONYX team is delighted to be recognized by these esteemed organizations and government boards,” says John Chuang, President of ONYX Healthcare USA, Inc. “It reflects our ongoing dedication to medical computing technology innovation without sacrificing product quality, patient safety, and service standard.”

To learn more about ONYX Healthcare USA, Inc. or to view their product catalogue, visit http://usa.onyx-healthcare.com.

About ONYX Healthcare USA, Inc.

ONYX Healthcare USA, Inc. is a subsidiary of the ASUS Computer Group that focuses on providing design manufacturing service for healthcare professionals and hospitals within medical OEM/ODM and healthcare IT markets. 

The company designs and manufactures a full line of medically certified (EN/UL 60601-1) fanless computing devices such as Surgical Workstation, Slim Medical Fanless Panel PC, Medical Tablet PC, Bedside Infotainment Terminal, and Embedded Motherboard, etc. through ISO9001/13485 regulated production procedure. 

For further details on ONYX Healthcare USA, Inc., please visit us at http://usa.onyx-healthcare.com.  

Calvin Cheng
Onyx Healthcare USA
Orange, CA

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Company Name: ONYX Healthcare USA, Inc.
Contact Person: Calvin Cheng
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Country: United States
Website: http://usa.onyx-healthcare.com/