Quality
Our commitment to excellence is demonstrated by the certifications listed below:
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 Registered Manufacturer: GCX is a registered contract manufacturer and manufacturer of Class I Medical Devices.
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.
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.
