Quality and Partnership

The GCX Quality Management System results in safe products and an exceptional end-user experience

Quality

Our commitment to excellence is demonstrated by the certifications listed below:

Iso

ISO 13485: The GCX quality management system is certified to ISO 13485:2016. ISO 13485 is the international standard that defines the quality system requirement for medical device manufacturers. Our ISO 13485 certification also includes our risk management process, which is certified to the requirements of ISO 14971. View Certificate

CE Mark: Most GCX products are CE Marked under the Machinery Directive 2006/​42/​EC. As we self-declare, GCX has the responsibility to determine which standards are appropriate to apply to our products. IEC 60601-1 is the written standard that contains safety requirements for medical devices, and several requirements in the mechanical section can be applied to GCX products. It is the standard that all our customers know and attempt to comply with. GCX tests to it by default. View Certificate

Fda

FDA Registered Manufacturer: GCX is a registered contract manufacturer and manufacturer of Class I Medical Devices.

Reachrohs

RoHS and REACH Compliant: GCX products are compliant to REACH Regulation 1907/​2006 and RoHS Directive 2011/​65/​EU, as amended by Directive EU/​2015/​863 within the European Union. This is indicated on our standard Certificate of Conformance, which is included with each shipment.

IEC 60601-1 Compliant: IEC 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment. As a designer and manufacturer of mechanical products only, GCX complies with the applicable section on mechanical safety. All other sections are not applicable. GCX performs in-house testing to verify compliance.

EUMDR

EU-MDR: While GCX products are not considered within the scope of EU-MDR, our Quality and Development teams regularly provide Quality and Regulatory support and guidance for our customers to ensure compliance with global standards and requirements such as EU-MDR.

Oem qp carts

150,000

MOBILE CARTS SHIPPED

Oem qp shipments

99.4%

ON-TIME SHIPMENTS

Oem qp defect free

99.8%

DEFECT-FREE PARTS

We work with more than 400 medical device manufacturers worldwide.

Abbott · Acist · Air Liquide · BD · Boston Scientific · Cadwell · Capsule · Dräger · EchoNous · Edwards · Fresenius Medical Care · FujiFilm · Fukuda Denshi · GE Healthcare · Getinge · Hillrom · Johnson & Johnson · Masimo · Medtronic · Mindray · Natus · Nihon Kohden · Nuvasive · Obix · Olympus · Philips · Smith + Nephew · Spacelabs Healthcare · Stryker · Vapotherm · Varian · Verathon · Zimmer Biomet · Zoll and more

Quality 1

A Responsive, Reliable, and Trusted Partner

  • Both standard and custom-configured products are thoroughly tested to IEC standards and validated by the world’s top medical device manufacturers.
  • GCX is regularly audited for ISO 13485 compliance by both a regulatory body, TUV, and our OEM customers. These auditors continuously note the strong customer focus and culture of quality embedded within our QMS.
  • GCX mounting solutions are in use throughout thousands of hospitals. Our components and accessories currently support more than 400 manufacturers’ devices used for patient monitoring, ventilation, ECG, ultrasounds, anesthesia, and IT.

Start a Project

Let’s work together to bring your next medical device or healthcare equipment to market quickly with our medical manufacturing experts and a custom-configured or brand new mounting solution.

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