News Releases

12/07/2018

ISO 13485:2016 Certification Complete

Ashaway, Rhode Island, USA, December 10th, 2018High Performance Medical Solutions (HPMS), a division of Hitachi Cable America Inc., is pleased to announce that the Hitachi Metals Suzhou, China cable assembly factory is now operating to the latest ISO 13485:2016 standard. This achievement brings both the U.S. Rhode Island facility and the Suzhou, China facility up to the latest standard and ahead of the March 21st, 2019 deadline for completion.

The latest 13485:2016 standard supports the more stringent regulatory demands required of the industry and puts new procedures in place that will significantly improve our global quality.

Eileen Archambault, VP of Quality Assurance and Compliance at High Performance Medical Solutions commented, “The transition to the new standard has been very beneficial to our organization. The recertification process was an excellent opportunity to increase the emphasis we place on risk management within our quality management system. Those improvements, along with ongoing risk reduction activities, pave the way for delivering high quality products that will be safer for end users”.

 

About Hitachi’s medical components in America:

To learn more about Hitachi Cable America, Inc. and the High Performance Medical Solutions division, please visit our website at http://www.hca.hitachi-cable.com/products/medical/medical-solutions.php.   

About Hitachi Metals, Ltd.

Hitachi Metals, Ltd., (TSE: 5486), headquartered in Tokyo, Japan, with consolidated revenue totaling 988 billion yen ($9.3 billion) in fiscal 2017(ended March 31, 2018). The company manufactures and markets a diverse portfolio of specialty steel products, magnetic materials and applications, functional components and equipment, wires, cables, and related products. For more information, visit www.hitachi-metals.co.jp/e/.

Inquiries:

Steven Kenney                                                       
Marketing Manager                                             
900 Holt Avenue                                                   
Manchester, NH 03109 U.S.A.                                                                          
+1 (603) 669-4347, ext. 229                              

Richard Roth
Dir. Business Development, Medical
15 Gray Lane, Phone
Ashaway, RI 02804 U.S.A.
+1 (603) 669-4347, ext. 288 U.S.A.