GCX Corporation receives certification as ISO 13485 supplier of medical devices

Petaluma, California, USA — 1月 28, 2013

PETALUMA, Calif. (Jan. 28, 2013) – GCX Corporation, the industry leader in mounting solutions, has received ISO 13485:2003 certification from registrar TUV USA.

“Being certified to the medical device standard solidifies the position of GCX as the leader in medical device and IT mounting,” according to Cris Daugbjerg, Vice President of Development. “The certification further aligns GCX quality management systems with the same standard that is implemented by the medical device manufacturers it serves,” he added.

“The additional requirements and rigors of the quality management system create substantial operational and development efficiencies, including benefits that are already realized through improved product quality, documentation and on-time delivery.”

GCX produces expertly engineered and customized products for original equipment manufacturers in addition to an internationally recognized line of off-the-shelf products that includes wall mounts, roll stands, ceiling mounts, countertop mounts, pole mounts and a variety of mounting accessories for virtually all health care settings.

“With greater focus on enabling caregivers to deliver patient care, the existing high-quality product, service, and responsiveness is extending to new heights,” said Director of Marketing Kevin Merritt.

ISO 13485 is an internationally recognized standard that defines the requirements of a quality management system for the design, manufacturing, and distribution of medical devices. The standard is based on ISO 9001, with additional requirements tailored to the regulatory environment surrounding medical devices.

TUV USA Inc., Salem, N.H., is an accredited third-party registrar that assesses and certifies management systems and regulatory inspection activities in the United States.

GCX社について

GCX Corp.は、カリフォルニア州ペタルマに本社を置き、1971年の設立以来、直販および相手先ブランド製造（OEM）により、医療機器およびITマウントソリューションを医療業界に提供しています。主な製品ラインは、ウォールマウント、ロールスタンド、カウンタートップマウント、ポールマウント、各種マウントアクセサリなど。GCXのマウントソリューションは、省スペースで人間工学に基づいた設計が特徴で、機器と患者のアクセスの両方を向上させる。同社は北米、ヨーロッパ、日本、台湾にオフィスを構えている。また、カリフォルニア州ペタルマ、テキサス州エルパソ、台湾新北市に倉庫と生産施設を運営している。詳細はwww.gcx.com。

PDF版を見る

最近のニュースとプレスリリース

すべて表示