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は1971年の創業以降、医療分野を専門に機器の特性や施設環境、医療関係者の方々のワークフローに配慮したマウントソリューションの開発に取り組んできました。これまでの歴史で培ってきた専門的な知識と経験によって、機能的で効率の良い医療環境をご提供します。